AIB International GMP Inspection Results Report

Transcription

1 AIB International GMP Inspection Results Report Consolidated Standards for Inspection: Food Distribution Centers Contacts Website US Office: 1213 Bakers Way PO Box 3999, Manhattan, KS (785) (800) Fax (785) UK Office: PO Box 11, Leatherhead, Surrey, KT22 7YZ Fax

2 The AIB International Consolidated Standards for Inspection are statements that represent key requirements that a facility must meet in order to keep products manufactured, processed or handled in a facility wholesome and safe The Standards reflect what an inspector would expect to see in a facility that maintains a food-safe processing environment This report details the findings from an AIB International inspection against the Consolidated Standards The document contains the following sections: Document Section Score and Rating Participant Names Facility-Specific Questions Location Matrices Findings with Risk Additional Comments Standards without identified Risks or Findings Standards Not Applicable x Description of the facility x Number of findings and related risks x Category scores and total score x Rating Description Personnel from the facility who accompanied the inspector Technical information about a facility For example: bulk materials used, temperature control equipment used Two matrices which categorize findings by Category and Risk Descriptions and recommendations related to all findings Comments made by the inspector that have no risk assessment Standards that are applicable to the inspected facility, but based on random review and observation samplings at the time of the inspection, the facility appears to be meeting requirements Standards that are not applicable to the inspected facility 2 of 20

3 The official version of this report is a certified pdf issued by AIB International Score and Rating Inspection Information: Facility Name Leonard's Express, Inc Standard Used Food Distribution Centers Facility Address 300 Piegeon Pt Rd New Castle, Delaware United States Products Produced Fresh produce (bananas, pineapples, mangoes, etc), miscellaneous dry food goods (baby food, bottled water, soda, etc) and non-food chemicals Account # Date(s) of Inspection Audit Type Inspection Type Announcement Type 14-Oct-2013 GMP Scored Expected Scope Reinspection No Variations From Expected Scope Terminated No Score Category Minor Issues Noted ( ) Improvement Needed ( ) Serious ( ) Unsatisfactory <= 135 Operational Methods and Personnel Practices Maintenance for Food Safety Cleaning Practices Integrated Pest Management Adequacy of Prerequisite and Food Safety Programs Total Score 820 Scores Disclaimer: AIB International Inc states that this report as dated and provided herein is to be construed as its findings and recommendations, category scores, total score, and rating A passing score of 700 and above is not a certification of the facility, products, or programs AIB International Inc does not accept or assume responsibility for the Prerequisite and Food Safety Programs in effect with the customer named on the title page of this report (the customer) AIB International Inc is only reporting the food safety conditions of the customer as of the date of this report and assumes no responsibility or liability as to whether the customer does or does not carry out the recommendations as contained in this report

4 Participant Names Leonard's Express, Inc Name Role Inspection Closing Meeting Dan Litz AIB Coordinator Yes Yes Jessica Lemasters Auditor Yes Yes 4 of 20

5 Facility-Specific Questions Leonard's Express, Inc # Question Comments 122 Does the site have temperature controlled areas such as coolers and freezers? 122a State the temperatures noted at the time of the inspection State if coolers are provided for quality or food safety purposes Yes The cooler #1 was at 58 degrees Fahrenheit, Cooler #3 at 58 degrees Fahrenheit, cooler #4 at 46 degrees Fahrenheit, Cooler #5 at 45 degrees Fahrenheit and Cooler #6 was at 42 degrees Fahrenheit during the inspection Cooler #2 was not operational during the inspection and was currently being utilized for the storage of ambient products for FDA inspection The coolers were provided for product quality purposes only 122b State the method of temperature monitoring (manual or continuous) The coolers were equipped with temperature monitoring devices that were manually checked on a daily basis 122c State if an alarm system is present The cooler temperature measuring devices were attached to an alarm system that was activated in the event the temperature parameters were exceeded 32 Does the facility use sanitizers on food contact surfaces? No 32a Is sanitizing followed by a potable water rinse, where required by the sanitizer label? 32b Is the sanitizer concentration verified? 32c Are corrective actions documented when results are not in compliance with label directions? 43 Does the site manage their pest control program under other guidelines? 43a State the guideline used 44 Are IPM services provided by a contractor? Yes 44a State the name of the service provider JC Ehrlich Pest Control 45 Does the site require the use of IPM professionals (ie, use of restricted use pesticides and/or state or national government regulations)? If yes, please state the reason No Contracted PCO s in the state of Delaware were required to have a commercial pesticide applicator's license with at least a 7A category and must work for a company with a pesticide business license when applying restricted use pesticides 45a State the expiration date of the PCO license(s) The primary technician responsible for servicing the facility 5 of 20

6 Leonard's Express, Inc 45b If licensing of the PCO is not required, were training records current? Yes was registered with the State of Delaware as an employee with Ehrlich and was currently operating under the supervisor's license which was current to December 31, c State the expiration date of the business license The business license was current to December 31, d State the expiration date of the certificate of insurance The certificate of insurance was current to October 1, Were pesticides used at this facility? Yes 46a List the names of the pesticides used, at a minimum, in the last 6 months or since the last AIB Inspection 46b Were current labels provided for the pesticides reviewed? Yes 46c Were current chemical safety data sheets provided for the pesticides reviewed? 52 Who was assigned responsibility for food safety at the facility? President 52a 52b Does the facility have a current license to produce, manufacture, or store food products (local health department, state, or other agency)? Has the site implemented procedures to meet regulatory requirements (ie, allergen labeling and control, Reportable Food Registry, Food Safety Modernization Act, etc)? 510 Does the site have a documented Microbiological Control Program in place? 510a State if testing is for sanitation, environmental, raw materials/finished product 510b State the microorganisms tested for 510c 510d 510e If the facility is testing for pathogens, indicate if the testing is environmental only or if testing is done for raw materials, finished products, or food contact surfaces If the site tests for pathogens, is the product or raw material placed on hold and not released until results indicating the food safety of the product have been obtained? Are documented disposition procedures and records in place for materials that test positive for pathogens? VMS Razor, EPA # ; VMS Weed Destroy, EPA # ; VMS Oust Extra, EPA # ; and Generation Blue Max Mini Blocks, EPA # Yes The facility maintained a current license with the State of Delaware that was current to December 31, 2013 No No 6 of 20

7 Leonard's Express, Inc 510f State if an in-house or outside lab is used 510g If an outside lab is used, are they accredited? List the accreditation body 511 Does this country have allergen regulations or does the site ship to countries with allergen regulations? 511a State the allergens handled at this facility No allergens were handled or stored at this facility 516 Has the site been inspected by a regulatory agency in the past year? No 516a State the name of the agency and the date of the inspection 516b State if the facility addressed findings identified in the regulatory inspection 525 Is there a HACCP program in place? No 525a List the CCP's 525b State if the plan has been validated and who did the validation 525c State the date of the most recent assessment 525d State the names of the products falling under regulatory HACCP produced or stored at this facility 529 How does the facility use potable water, ice, or steam for product contact? 529a State the source of the potable water supply (well, city, etc) Municipal Yes No Water was only utilized for general housekeeping tasks and maintenance of personal hygiene practices 529b State the source of the records indicating potability The 2012 Water Quality Information Consumer Confidence Report for United Water Owego-Nichols System was provided during the inspection 529c Is ice made in-house or purchased? 529d 529e List the source of testing records for ice and if they indicated that it was potable Is food approval documentation provided for chemicals used for the generation of steam for food contact? 529f List the source of testing records for steam used for product contact 529g State if the back flow prevention devices are checked for function and provide the last date of testing The facility did not have back flow prevention devices installed as outlined further in standard within the text of this report 7 of 20

8 Findings by Location and Category Leonard's Express, Inc Locations Operational Methods and Personnel Practices Maintenance for Food Safety Cleaning Practices Integrated Pest Management Adequacy of Prerequisite and Food Safety Programs Facility Overview Outside Grounds and Roof Computer Shed Coolers Totals by Category Totals by Location Locations Findings by Location and Risk Minor Issues Noted Improvement Needed Serious Unsatisfactory Facility Overview Outside Grounds and Roof Computer Shed Coolers Totals by Risk Totals by Location 8 of 20

9 Findings with Risk Leonard's Express, Inc # Risk Standard Standard # Requirement # Location 1 Serious (S) Overhead Structures Coolers Drips and condensation were not controlled Specifically, condensation was observed in several locations on the ceiling surfaces in Cooler #5 which was positioned directly above the exposed fruit products stored below A discolored residue was also noted on the ceiling surfaces throughout the cooler as outlined further within the Cleaning Practices section of this report The condensation in Cooler #5 appeared to be primarily located along the joints where the ceiling panels connected In addition, condensation was noted on the back right cooling unit in Cooler #3 along the lateral, bottom and fan housing surfaces As the unit was operating the water was being distributed onto the products in storage; however, these products were individually wrapped in plastic somewhat mitigating the product risk Recommendation: The presence of condensation positioned above exposed products in storage presents a significant-severe risk of product contamination It was recommended that the source of the condensation be investigated and measures be implemented to prevent recurrence The presence of the condensation along the ceiling panel joints in Cooler #5 may indicate potential integrity breaches allow warmer air to enter the cooler contributing to formation of condensation It was also recommended that the cooling unit in Cooler #3 be evaluated for operational issues leading to the development of condensation on the unit surfaces 2 Improvement Needed (IN) Cross Contamination Prevention Facility Overview A few doors were found to be left open during the inspection creating a pest ingress opportunity Specifically, dock door #6 and the forklift door by exterior bait station #10 were found to be left open and unattended In addition, the top adjustable tarp above dock door #1 was observed to not have been fitted properly for the current truck creating direct openings to the exterior grounds A review of the pest control records and random review of exterior bait stations indicated recent presence of exterior rodent pressure Recommendation: It was recommended that the facility ensure personnel keep all exterior doors closed to inhibit the entrance of pests into the building which could lead to infestation and product contamination Personnel should be trained on the importance of door management 3 Improvement Needed (IN) Health Conditions Facility Overview No blood borne/bodily fluids policies and procedures exist for this facility Recommendation: It was recommended that the facility develop and enforce written procedures for the handling/disposition of food and product contact surfaces that may have come into contact with blood or other bodily fluids to inhibit the potential contamination of products 4 Improvement Needed (IN) Walls Outside Grounds and Roof Holes or cracks were noted in wall surfaces Specifically, the exterior wall beneath dock door #9 was found to be damaged with the interior surfaces exposed creating a potential pest attraction and harborage point A review of the pest control records and random review of exterior bait stations indicated recent presence of exterior rodent pressure Recommendation: It was recommended that the damaged wall section be promptly cleaned and repaired to facilitate pest control activities 9 of 20

10 Leonard's Express, Inc 5 Improvement Needed (IN) Pest Prevention Facility Overview Openings to the exterior grounds were noted along the lateral right seal of dock door #5 The facility maintained a total of nine dock doors and a review of the pest control records and random review of exterior bait stations indicated recent presence of exterior rodent pressure Recommendation: It was recommended that the identified opening be sealed to eliminate the potential pest entry point 6 Improvement Needed (IN) Product Zone Cleaning Facility Overview A moderate accumulation of dust was observed on the overhead structures above the office area and Coolers #4 and #5 An accumulation of dust and debris was also observed in the corridor behind Cooler #6 and Cooler #4 In addition, a discolored residue was also noted on the ceiling surfaces throughout the Cooler #5 with the heaviest accumulation located in front of the cooling units Recommendation: It was recommended that these noted areas be promptly cleaned and that the cleaning in these locations become more frequent and/or detailed 7 Improvement Needed (IN) Insect Light Traps Facility Overview The insect light traps were currently only being serviced once per month A review of the pest trending results demonstrated evidence of flying insect pressure, especially during the warmer months Recommendation: It was recommended that the insect light traps be serviced on a minimum of a weekly basis during the active season and a monthly basis during colder seasons 8 Improvement Needed (IN) Accountability Facility Overview No written procedures to meet legislative requirements were documented and personnel were not aware of their responsibilities for implementation Recommendation: It was recommended that the facility define written procedures to meet legislative requirements as defined by country or export requirements (eg allergen labeling and control, Reportable Food Registry, Food Safety Modernization Act, etc) The facility should be aware of the program and its role in implementing the requirements 9 Improvement Needed (IN) Self-Inspections Facility Overview Self-inspections were conducted by the Food Safety Committee However, issues were identified during the AIB inspection that could have been identified during these inspections and corrected Recommendation: It was recommended that continued emphasis be placed on ensuring that these inspections become more detailed in identifying and promptly eliminating all significant and potential food safety hazards such as the findings noted during the AIB International inspection and outlined in the text of this report 10 Improvement Needed (IN) Chemical Control Program Facility Overview The Chemical Control Program did not address all procedures that were applicable to this facility Specifically the written program did not capture chemical approval, purchase authority, inventory control, chemical disposal, container disposal and spill containment and control Recommendation: It was recommended that the program be further developed to capture the aforementioned requirements to demonstrate control of chemicals and ensure conformance with the AIB Consolidated Standards for Inspection 11 Improvement Needed (IN) Preventive Maintenance Program Facility Overview It was understood that the majority of required maintenance was outsourced to external contractors as determined 10 of 20

11 Leonard's Express, Inc Recommendation: necessary A schedule was established outlining the work tasks to be completed internally and externally The facility utilized a work order system to prioritize problems in structural, equipment and/or utensil maintenance However, a few maintenance opportunities were identified during the inspection that indicated an opportunity with the implementation of the PM program as outlined within the "Maintenance for Food Safety" section of this report It was recommended that continued emphasis be placed on ensuring that the maintenance program become more detailed in identifying and promptly eliminating all significant and potential food safety hazards such as the evidence of condensation in the coolers and pest entry points as observed during the AIB International inspection and outlined in the text of this report 12 Minor Issues Noted (MI) Washrooms, Showers, and Locker Rooms Computer Shed Wash hands signs were missing in some employee welfare areas Specifically, a sign was not posted in the Computer Shed which was an authorized eating area and designated outside smoking area Recommendation: It was suggested that a sign be placed in this location to remind personnel to comply with personal hygiene practices after eating 13 Minor Issues Noted (MI) Cross Contamination Prevention Facility Overview Back siphonage devices were not provided and maintained to prevent back flow and back siphonage It was taken into consideration that the facility did not handle or rework exposed products and water was not utilized for direct product contact purposes Recommendation: It was suggested that back siphonage devices be installed and maintained Routine checks should be performed on the devices to verify that they are functioning properly and results should be documented In addition, back siphonage and back flow prevention units should be identified in the Preventive Maintenance Program 14 Minor Issues Noted (MI) Temperature Measuring Devices Facility Overview Temperature measuring devices used in processes not critical to food safety were calibrated on a weekly basis to a defined national standard; however, the facility was currently only recording the results of the hand-held thermometer and not the storage room temperature to demonstrate effective calibration Recommendation: It was suggested that the facility further develop the documentation to include the temperature of the hand-held and storage room temperatures as evidence of calibration 15 Minor Issues Noted (MI) Bird Control Outside Grounds and Roof Evidence of old bird nesting was observed within the interior housing surrounding the exterior personnel door located off of the empty room connected to Cooler #6 The exterior of this door was examined and found to have been effectively sealed with wire and netting; however, the nesting material had not been removed No products were stored in this room Recommendation: It was suggested that the facility remove the remnants of the bird nesting material and thoroughly clean the area 16 Minor Issues Noted (MI) Training and Education Facility Overview Annual refresher training was provided and current However, opportunity in provision of refresher training was noted regarding the management of closing doors when not in use Recommendation: It was suggested that emphasis be placed on providing retraining to personnel regarding the proper management of doors to facilitate pest control activities 17 Minor Issues Noted (MI) Cleaning Program Facility Overview 11 of 20

12 Leonard's Express, Inc Recommendation: The cleaning schedule did not currently define procedures for the cleaning of the ceiling surfaces of the coolers and corridors behind the coolers It was suggested that the facility develop written cleaning procedures for these locations to ensure maintenance of a sanitary environment for food storage 12 of 20

13 Additional Comments Leonard's Express, Inc # Risk Standard Standard # Requirement # Location 1 Finished Product Transportation Written transportation breakdown procedures were on file at the facility The "Drivers Manual & Standard Operating Procedures, Section 12 Communications and Management Responsibilities (#3-5)" was reviewed during the survey 2 Health Conditions Effective procedures were in place within the "Personal Hygiene and Preventing Contamination" (Policy 106-1B) to ensure that personnel with boils, sores, infected wounds, infections, or other communicable diseases were not permitted to come in contact with food as required by law 3 Health Conditions Procedures requiring personnel, including temporary workers, to notify supervisors of infections or disease that they may have been exposed to were in place within the "Personal Hygiene and Preventing Contamination" (Policy 106-1B) 4 Comments Outside Grounds and Roof Facility Overview The roof was unable to be examined due to limited access 5 Comments Equipment and Tools Facility Overview Separate utensils with an established identification system based on their intended use were not needed at this location as there were no food contact surfaces requiring cleaning 6 Comments Equipment and Tools Facility Overview Separate utensils with an established identification system based on their intended use were not needed at this location as there were no food contact surfaces requiring cleaning 7 Facility Assessment The annual facility assessment was documented and current The most recent assessment was conducted on October 3, Facility Assessment Documentation of findings and Corrective Actions was provided based on the assessment However, no findings were noted during the most recent assessment that required implementation of corrective actions 9 Facility Assessment Trained contracted pest control personnel completed the assessment 10 Insect Light Traps ILT light tubes were changed on an annual basis at the beginning of the active season The bulbs were last changed on 13 of 20

14 Leonard's Express, Inc July 11, Written Policy The facility had a documented "Food Safety Policy Statement" (dated August 2013) outlining its commitment to produce, store and distribute safe and legal products 12 Written Policy The statement was signed by the President 13 Written Policy The policy is communicated throughout the facility This was accomplished through performance of orientation and annual GMP training The policy was also observed to be visibly posted in the facility 14 Training and Education There was a formal program for developing and delivering Prerequisite and Food Safety training to personnel The "Training & Development Policy" was reviewed during the survey 15 Written Procedure Audits A risk-based audit of procedures was documented by competent inspectors at least annually The most recent audit was completed on April 8, Customer Complaint Program A written program for evaluating customer complaints was established The Customer Complaint Policy (Policy #309003) was reviewed during the survey 17 Chemical Control Program A written Chemical Control Program that addresses all chemicals used in the facility was established The "Diamond State Warehouse Chemical Control Program" was reviewed during the survey 18 Allergen Control Program The food distribution center did not handle or produce products containing allergens However, an "Allergen Audit" was performed on August 28, 2013, as evidence that a risk assessment had been performed confirming that no allergens or chemical sensitive ingredients were handled or utilized in the facility 19 Glass, Brittle Plastics, and Ceramics Program The facility had a written policy stating that no glass, brittle plastics, or ceramics were to be used in the facility except where absolutely necessary The "Glass, Ceramics and Brittle Plastics Policy" (Policy #103-02) was reviewed during the survey 20 Glass, Brittle Plastics, and Ceramics Program Included in the policy was a procedure to handle any breakage in the facility A list of all essential glass, brittle plastics, and ceramics was developed, and scheduled daily and/or monthly inspections were conducted 14 of 20

15 Leonard's Express, Inc 21 Receiving Program A written Receiving Program was in place for the facility The "Receiving, B Transportation, Receiving & Storage" (SOP B01) was reviewed during the survey 22 Regulatory Affairs and Inspection Program A written Regulatory Affairs and Inspections Program was on file The Program included a list of personnel delegated to accompany all inspectors along with the company policy regarding recording devices, cameras, records, and sample taking The "Third Party Inspection" (Policy #104-02) was reviewed during the survey 23 Food Defense Program The facility had conducted a Vulnerability Assessment to identify food defense risks The most recent assessment was completed on July 15, Traceability Program A written Traceability Program was implemented for this facility The "Product Traceability Policy" (Policy #108-02) was reviewed during the survey 25 Traceability Program The Program addressed identification of lot numbers of finished product and distribution 26 Recall-Withdrawal Program A written Recall-Withdrawal Program was on file The "Handling a Food or Other Product Recall or Market Withdrawal" (Policy #109-01) policy was reviewed during the survey 27 Recall-Withdrawal Program The Recall Program was tested twice annually and test results were documented and included the success rate and the time it took to complete the exercise The most recent test was performed on July 14, Nonconforming Product Program A written Program was in place to control nonconforming products, finished products and returned goods The "Nonconforming Products Policy" (Policy #110-01) was reviewed during the survey 29 Release Procedures Release procedures were defined for raw materials or finished products used at this facility The "Release Procedures" were reviewed during the survey 15 of 20

16 Standards without identified Risks or Findings Leonard's Express, Inc Based on random review and observation samplings at the time of the inspection, the facility appears to be meeting the requirements of the following Standards: Standard Standard # Standard Goal Rejection of Shipments/Receipt of Dry Goods Rejection of Shipments/Receipt of Perishables 11 Random review of records and programs related to safeguarding of food products by identifying and barring entry to potentially contaminated raw materials indicate they met the requirements of the standard as applicable to this site 12 Random review of the records and programs related to receipt of perishable products by identifying and barring entry to potentially contaminated raw materials indicate they met the requirements of the standard as applicable to this site Storage Practices 13 Materials appeared to be stored in a way that met the program requirements as defined by this site, as well as the applicable requirements in the standard Storage Conditions 14 Raw materials and finished products appeared to be stored in a clean storage area and were protected from contamination as observed during the inspection Raw Material/Finished Product Inventory 15 Raw material and finished product inventories appeared to be maintained at a reasonable volume Random review of materials did not identify aged or infested materials during the inspection Pallets 16 Pallets examined were found to be clean and well maintained Waste Material Disposal 116 Waste material and waste material removal were managed to avoid product contamination Temperature-Sensitive Materials 122 Appropriate storage temperatures were noted during the inspection to prevent microbial growth in susceptible food products Finished Product Transportation 126 Transportation and finished product coding randomly reviewed during the inspection was provided in a manner to allow traceability of materials Transports examined during the inspection were found to be clean and in good condition Hand Washing Facilities 127 Hand washing facilities examined during the inspection appeared to be appropriately located, functional, and stocked to allow hand washing to occur Personal Hygiene 129 No personal hygiene practices issues were identified during the inspection Personal Items and Jewelry Control 132 No issues with the control of jewelry or personal items were identified during the inspection Non-Facility Personnel 134 Non-facility personnel were observed to be in compliance with the facility defined GMP Programs Facility Location 21 No evidence of issues from local activities or the facility location were identified during the inspection 16 of 20

17 Leonard's Express, Inc Outside Grounds and Roof 22 Facility grounds appeared to be well maintained No issues were identified Security Equipment 23 Physical security measures were implemented at this facility Layout 24 No issues with placement of equipment and structures were identified Appropriate access for cleaning, inspection, and maintenance activities was noted Floors 25 Floor surfaces observed during the inspection were found to be in good condition Drains 26 Drains examined during the inspection were found to be in good condition Glass, Brittle Plastics, and Ceramics Control 29 No issues with glass, brittle plastics, or ceramics were identified during the inspection Transporting Equipment 219 Transporting equipment appeared to be well maintained at the time of the inspection Parts Storage 220 Parts were found to be clean and properly stored at the time of the inspection Hand Washing Facilities Design 221 Hand washing facilities were provided and were observed to be operational during the inspection Cleaning 31 Cleaning appeared to be completed in a way to prevent contamination of raw materials, products, and equipment Food Contact Cleaning Compounds and Sanitizers 32 Approval and verification procedures were in place for cleaning compounds and sanitizers used at the facility for food contact cleaning Approval documentation was provided for the chemicals that were selected and reviewed Equipment and Tools 33 Cleaning tools and equipment appeared to be managed and maintained to prevent product contamination No issues were identified Daily (Housekeeping) Cleaning 34 No issues were identified with daily housekeeping practices observed during the inspection Non-Product Zone and Support Area Cleaning Integrated Pest Management (IPM) Program 36 Non-product zone and support area cleaning appeared to be completed No issues were identified 41 A written IPM Program outlining controls and processes to minimize pest activity were defined Facility Assessment 42 An annual assessment of the IPM Program was documented and current Signed Contracts 44 Signed contracts between the facility and the external service provider defined the requirements for pest management activities for this facility Credentials and Competencies 45 Qualifications examined for selected IPM service providers were documented and current Pesticide Documentation 46 Pesticide labels and chemical safety data sheets were provided for the pesticides randomly examined during the inspection Pesticide Application Documentation 47 Pesticide application documentation was current and provided records to identify, document, and verify use of pesticides randomly examined during the inspection 17 of 20

18 Leonard's Express, Inc Trend Analysis 49 Service records of monitoring devices and pest sightings reviewed appeared to be used to identify and eliminate areas of pest activity as noted by the lack of significant activity observed during the inspection Monitoring Device Documentation 410 Monitoring devices were mapped and maintained to ensure proper placement and monitoring for pest activity and trending The map appeared to be current based on observation during the inspection Exterior Rodent Monitoring Devices 411 Exterior rodent control devices were placed and those randomly reviewed were maintained to provide rodent monitoring and to deter entry into the facility Interior Rodent Monitoring Devices 412 Interior rodent monitoring devices were placed and those randomly reviewed were maintained to identify and capture rodents that have gained access to the facility Wildlife Control 416 No issues with identification or elimination of wildlife habitat were noted Pest Habitat 417 No evidence of rodent, bird, insect, or other pest issues were identified during the inspection Written Policy 51 A written policy emphasizing the facility's commitment to provide safe and legal food products was documented for this facility Support 53 Human and financial resources were provided to support implementation of the Food Safety and Prerequisite Programs Written Procedures 54 Written procedures randomly reviewed for food safety activities at the facility defined owners, actions, and timelines Written Procedure Audits 57 Written procedure audits were documented to validate the appropriateness and implementation of procedures defined for this site Records randomly reviewed indicated that audits were conducted and current Customer Complaint Program 58 A Customer Complaint Program was implemented to respond to customer concerns Protocols were in place to ensure that food safety issues were responded to in a prompt and effective manner, whether it be at the facility level or as managed by corporate Allergen Control Program 511 Allergen controls were implemented to identify allergen control throughout the process from receiving to distribution of product Random review of the program, records, and observations during the inspection indicated that the program was implemented Glass, Brittle Plastics, and Ceramics Program 512 A documented Glass, Brittle Plastics, and Ceramics Program was provided to identify processes that prevent contamination of product There were no identified deficiencies noted during the inspection to indicate that the program was ineffective Receiving Program 515 The Receiving Program implemented at the facility outlined and identified requirements for the raw materials received at this site Random review of the program and documentation of receipt of materials indicated that materials receipts were consistent with the defined program requirements Regulatory Affairs and Inspection Program 516 A documented Regulatory Affairs and Inspections Program provided instructions for handling 18 of 20

19 Leonard's Express, Inc of regulatory, third party, and customer inspections Food Defense Program 517 A Vulnerability Assessment was performed to identify and reduce the risk of intentional harm to the facility, its personnel, and food products No inconsistencies with the Food Defense Program, as defined for the facility, were identified during the inspection Traceability Program 518 The written Traceability Program defined the methodology to allow quick location of suspect raw materials, food contact packaging materials, rework, and related finished products Recall-Withdrawal Program 519 The written Recall/Withdrawal Program documented the procedures for quick and controlled recovery of product from the market Random review of the records and mock recovery exercises indicated that the program was implemented as defined for this facility Nonconforming Product Program 520 The Nonconforming Products Program defined the guidelines for isolation, investigation, and disposition of raw materials, packaging materials, work-in-progress, returned goods, and finished products as applicable to the facility Random review of records and observations during the inspection did not identify any current deficiencies with this program Release Procedures 527 Release procedures as defined for this facility were implemented to ensure that materials were checked for food safety hazards prior to release and shipment to the customer Water Quality 529 Water, water sources, and water management strategies were implemented to ensure safe water for product contact and use Random reviews of the records indicated that programs were implemented 19 of 20

20 Standards Not Applicable Leonard's Express, Inc Standard # Standard Name 17 Designated Rework Areas 110 Sampling Procedures 120 Single-Service Containers 124 Containers and Utensils 210 Air Makeup Units 212 Leaks and Lubrication 215 Equipment and Utensil Construction 216 Temporary Repair Materials 223 Ammonia Control 43 Other Guidelines 48 Pesticide Control 414 Pheromone Monitoring Devices 510 Microbial Control Program 525 HACCP Program 20 of 20