NEVADA ESTABLISHMENT INSPECTION REPORT FOR FOOD State of Nevada Inspection FIRM INFORMATION COLLECT BUSINESS CARD NO BUSINESS CARD AVAILABLE

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1 NEVADA ESTABLISHMENT INSPECTION REPORT FOR FOOD State of Nevada Inspection Audit Inspection Training/Verification Audit Inspection Of State Auditor Complaint Inspection FIRM INFORMATION COLLECT BUSINESS CARD BUSINESS CARD AVAILABLE Business card spot REASON AND SCOPE OF INSPECTION This was in inspection conducted under the Nevada Division of Public and Behavioral Health Contract. <Insert short statement regarding business model> FACILITY INFORMATION FIRM LEGAL NAME: INSPECTION DATE(S): Click or tap to enter a date. DBA OR NEW BUSINESS NAME: FEI-NUMBER: DUNS: UNKNOWN MAILING ADDRESS (INCLUDING ZIP CODE): PHYSICAL ADDRESS (INCLUDING ZIP CODE): BUSINESS ENTITY PHONE: MOST RESPONSIBLE PERSON/PERSON IN CHARGE: WEBSITE: MRP/PIC - PHONE: FACILITY LOCATION NUMBER OF EMPLOYEES: FULL TIME: PART TIME: SEASONAL/ TEMPORARY: FACILITY GROSS ANNUAL FOOD SALES: 0-24,999 25,000-49,999 50,000-99, , , , ,999 1,000,000-4,999,999 5,000,000-9,999,999 10,000,000-24,999,999 25,000,000-49,999,999 50,000,000- and over Unknown Version 10/19/2017

2 NAME OF CORPORATE ENTITY: CORPORATE INFORMATION CORPORATE PHONE: PHYSICAL ADDRESS (INCLUDING ZIP CODE): LIST OF CORPORATE OFFICERS IN THE FIRM: CORPORATE LOCATION NUMBER OF EMPLOYEES: >500 Unknown CORPORATE GROSS ANNUAL FOOD SALES: < 249, , , , ,999 1,000,000-2,499, , ,999 > 2,500,999 Unknown SEND FDA CORRESPONDENCE TO (NAME AND TITLE): Facility Address Or At The Following Mailing Address: LEGALLY RELATED FIRMS PRODUCT CODE INFORMATION APPLICABLE HUMAN FOOD INDUSTRY TYPES AND PRODUCT CODE INFORMATION: (You may use multiple rows) Industry Product Code BIOSECURITY / BIOTERRORISM ACT (BTA) AND GMP/PREVENTIVE CONTROLS IS THE FIRM REGISTERED WITH FURLS? IS THE FIRM A REGISTERED (BTA) FOOD FACILITY WITH FDA? FIRM S FDA REGISTRATION NUMBER: Requested Unknown Eleven Digits DOCUMENTATION Bioterrorism (BT) REGISTRATION REQUIREMENTS DISCUSSED WITH MANAGEMENT? BT REGISTRATION BOOKLET GIVEN TO MANAGEMENT? Section 415(a)(3) requires facilities that are required to register. Renewals occur every other year, beginning on October 1 - December 31 (in even years) PREVENTIVE (PC) HUMAN AND/OR ANIMAL FOOD FACT SHEET WAS OFFERED TO THE FIRM: THE SANITARY TRANSPORTATION OF HUMAN AND/OR ANIMAL FOOD FACTSHEET WAS OFFERED TO THE FIRM: THE INTENTIONAL ADULTERATION (IA) OF HUMAN FOOD FACTSHEET WAS OFFERED TO THE FIRM (HUMAN ONLY) REPORTABLE FOOD REGISTRY (RFR) HANDOUT GIVEN TO FIRM? Version: 10/12/2017 2

3 GMP Preventive Controls Summary Does the firm manufacture or handle human food: The firm has Good Manufacturing Practices (GMP s) in place: The firm has a written Food Safety Plan: The firm has conducted a Hazard Analysis: The firm has an Environmental Monitoring Program: The firm has a Recall Plan: The firm is an Importer: FIRM DESCRIPTION / INSPECTIONAL COVERAGE BRIEF HISTORY OF FIRM: DESCRIBE THE RESPONSIBILITIES OF THE MOST RESPONSIBLE PERSON PRESENT AT THE TIME OF THE INSPECTION. (PROVIDE NAME AND TITLE) DESCRIPTION OF FIRMS CUSTOMERS (DISTRIBUTORS, MARKETS, RESTAURANTS, ETC): Other: FDA INSPECTIONAL HISTORY-PREVIOUS VIOLATIONS U.S. FOOD AND DRUG ADMINISTRATION THIS FIRM HAS BEEN INSPECTED BY THE FDA LAST FDA INSPECTION DATE: Click or tap to enter a date. WAS A FDA FORM 483 ISSUED? THIS FIRM HAS NEVER BEEN INSPECTED BY THE FDA. COMMENTS FROM ABOVE IF NECESSARY LOCAL HEALTH AUTHORITY INFORMAITON NEVADA DIVISION OF PUBLIC AND BEHAVIORAL HEALTH-ENVIRONMENTAL HEALTH SECTION NEVADA DEPARTMENT OF AGRICULTURE DAIRY PRODUCE MEATS SOUTHERN NEVADA HEALTH DISTRICT (CLARK COUNTY) WASHOE COUNTY DISTRICT HEALTH DEPARTMENT (WASHOE COUNTY) CARSON CITY HEALTH AND HUMAN SERVICES (CARSON CITY) DOUGLAS COUNTY HEALTH DEPARTMENT PERMIT # EXPIRATION DATE: INSPECTION DATE: ISSUES: VIOLATIONS OR COMMENTS: LIST CORRECTIVE ACTIONS SINCE LAST INSPECTION: WHAT OTHER GOVERNMENTAL OR PRIVATE AGENCIES THAT REGULATE AND INSPECT THE FIRM? FDA USDA NDEP BLM KOSHER EPA ORGANIC NSF SQF Halal AIB ARMED SERVICES: OTHER: Version: 10/12/2017 3

4 SERVED BY THE FIRM PERCENT OF PRODUCT DESCRIPTION OF FIRMS CUSTOMERS % Inside Nevada % Out of State % Export % Interstate %Wholesale % Retail Distributors Further Processing Restaurants Grocery Stores Institutions GEOGRAPHY Hospitals Schools Prisons BUILDING / FACILITY DESCRIPTION HOURS & DAYS OF Sun M Tu W Th F Sa OPERATION Hours: LOCATION: Industrial Park Commercial/Residential Rural Other CONSTRUCTION MATERIAL: Brick Concrete Wood Steel Metal NUMBER OF STORIES: One Two Three With Loft or Mezzanine areas SQUARE FOOTAGE: < 1,000 sq. ft. 1,000-3,000 sq. ft. 3,001 5,000 sq. ft. (+) 5,000 sq. ft. Actual Square Footage (if available): Number of Buildings: OTHER OCCUPANTS: No other occupants Other occupant(s): STORAGE: Refrigeration Storage Walk-in Reach-in Freezer Storage Walk-in Reach-in N/A Walk-in Reach-in GARBAGE: (SALVAGE) Commercial Self-Hauling RENDERING: Rendering Composting Distributed to farmers for feed N/A Comments: GREASE INTERCEPTOR: Not Applicable or State Gallons: WATER SOURCE: WATER TESTING: Choose an item. SEWAGE: Choose an item. Community Private Well (Exempted) Public Water System w/permit Comments: Time period applicable to testing is far left column: Bacteriological Date: Click or tap to enter a sampling: (Total date. Coliform and E-Coli): FHA-Short Series: Coliform, lead, nitrate, nitrite etc: Date: Click or tap to enter a date. Community Septic System Engineered System Comments: Positive Negative Positive Negative Version: 10/12/2017 4

5 CLEANING CHEMICALS: PRODUCT VENDOR NUMBER: Vehicles TYPES OF VEHICLES USED: DOES THE FIRM UTILIZE? Common Carrier FEDX/UPS Mail Order Air Freight Customer Pick Up Comments: FOOD PRODUCTION THE FIRM MANUFACTURES THE FOLLOWING FOOD ITEMS UNDER FDA/NEVADA JURISDICTION LIST PRODUCTS WHICH ARE: (1) PRODUCED (2) REPACKED (3) STORED Produced Repacked Stored SUPPLIER(S) FOR INGREDIENTS USED IN PRODUCTS(S) PRODUCED (INLCUDE FIRM NAME, CITY, AND STATE) OR FINISHED PRODUCT SUPPLIER(S): EX: FOOD, SPICES, AND INGREDIENTS ETC. Ingredients Firm Name and Address DURING THE INSPECTION, THE FIRM WAS EX: PROCESSING/CUTTING, COOKING, ETC. Lot # DESCRIBE ANY MANUFACTURING LOT CODE PRACTICES, PROVIDE KEY TO INTERRETATION OF CODES: Lot # Lot # Lot # I OBSERVED THE FOLLOWING OPERATIONS: Version: 10/12/2017 5

6 DESCRIBE PROCESSING EQUIPMENT USED BY THE FIRM: See equipment list page for a general list of types of equipment used at a food processing firm DOES THE FIRM CONDUCT ANY PRODUCT OR ENVIRONMENTAL TESTING OR RECEIVE CERTIFICATE OF ANALYSIS? DESCRIBE. MICROBIAL (RAW AND FINAL PRODUCT) AND ENVIRONMENTAL? ANY POSITIVE RESULTS? DESCRIBE: Microbial testing for raw product: Microbial testing for final product: Environmental Monitoring: ATP Test Allergen Protein Test Internal Lab Test External lab test DESCRIBE PACKAGING (EX: BOTTLES, CANS, BAGS, ETC.) TYPE OF PACKAGING VENDOR INFORMATION Certificate of Assurance Maintained? Comments HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP) PROGRAM? DOES THE FIRM HAVE A HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP) PROGRAM? IS IT CURRENT AND IN COMPLIANCE? (Check Signature and Date) ARE RECORDS/LOGS COMPLETE AND IN COMPLIANCE? HACCP PLAN COVERS WHAT PRODUCTS? HACCP COMMENTS: RECORDS REVIEW: Version: 10/12/2017 6

7 FOOD SAFETY PLAN Has a Hazards Analysis been conducted to identify hazards requiring Preventive Controls (PC) Rules? What are the hazards? Preventive Controls Qualified Individual (PCQI). Provide Name, Title and Affiliation to Firm Food Safety Team, if applicable (Name, Position, Applicable Training i.e. in plant training or class) Not Applicable Preventive Controls (PC) for? Written Plan? Describe, FSP, Process controls FSP, Food Allergen Controls/Labels FSP, Sanitation Controls FSP, Supply Chain Controls FSP, Recall Plan Other: Other: Implementation Procedures Validation Studies Equipment specs, Lab tests, COA etc Parameters and Values Monitor Frequency of testing, performance monitoring Verification Validation, Calibration, Records Review Corrective Actions Identify issues, Revaluation of CA s Records FSP, process controls, monitoring, corrective actions, verification, training ALLERGEN CONTROL PLAN DOES FIRM HAVE A CURRENT ALLERGEN CONTROL PLAN? ALLERGEN PLAN COVERS WHAT PRODUCTS? MILK EGGS FISH CRUSTECEAN SHELLFISH TREE NUTS PEANUTS WHEAT SOY COMMENTS: RECORDS: Version: 10/12/2017 7

8 DOES THE FIRM HAVE A PEST CONTROL PLAN? ARE RECORDS AND LOGS COMPLETE AND IN COMPLAINCE? COMMENTS: PEST CONTROL RECORDS REVIEWED: Provide Dates Reviewed and Issues IS NUTRITION LABELING AND EDUCATION ACT (NLEA) REQUIRED? IF NELA EXMEMPT, EXPLAIN WHY? NUTRITION LABELING NUMBER OF LABELS REVIEWED: (Collect copies 3 of each label) LABELS ATTACHED: N/A FINDINGS: RECALL PROGRAM DOES THE FIRM HAVE RECALL PROCEDURES? ARE MOCK RECALLS CONDUCTED? HOW OFTEN ARE MOCK RECALLS CONDUCTED? Choose an item. Date of Last Mock Inspection: Product Reviewed: HAVE THERE BEEN ANY ACTUAL RECALLS SINCE THE LAST INSPECTION? WAS A REPORT FILED WITH THE FDA? IF YES INDICATE REASON: NAME OF RECALL PERSON? (Phone Number) COMMENTS: RECORDS REVIEWED: Version: 10/12/2017 8

9 COMPLANT PROGRAM DO THEY HAVE A COMPLAINT PROGRAM PLAN? HAS THE FIRM RECEIVED ANY CONSUMER COMPLAINTS IN THE LAST YEAR? IF THE FIRM RECEIVED ANY CRITICAL COMPLAINTS, DESCRIBE THE NATURE OF THE COMPLAINT AND ACTIONS TAKE BY THE FIRM: RECORDS REVIEWED: EMPLOYEE SANITATION, HEALTH AND FOOD SAFETY AND DEFENSE TRAINING PROGRAM DO THEY HAVE AN EMPLOYEE SANITATION PROGRAM? DURING THE INSPECTION, DID YOU OBSERVE: (MARK ITEMS OBSERVED) HANDWASHING, GLOVE USE HAIR NETS/COVER OUTER GARMETS CLEAN MAINTAINING ADEQUATE PERSONAL CLEANLINESS JEWELERY SECURED PERSONAL ITEMS SECURED FOODS SECURED DO THEY HAVE AN EMPLOYEE HEALTH PROGRAM OR POLICY? DOES IT COVER SYMPTOMS OF FOODBORNE INFECTIONS INCLUDE? POLICY COVERS: DIARRHEA, VOMITING, FEVER, HEADACHE, JAUNDICE HOW IS TRAINING PROVIDED TO EMPLOYEES? VIDEO HANDBOOK CLASSROOM POWERPOINTS DO THEY HAVE AN FOOD DEFENSE TRAINING PROGRAM? (i.e., Describe Security Policy) RECORDS REVIEWED: MAINTENANCE, EQUIPMENT AND CALIBRATION PROCEDURES DOES THE FIRM HAVE MAINTENANCE, EQUIPMENT AND CALIBRATION PROCEDURES? ARE PROCEDURES WRITTEN IN TO A STANDARD OPERATING PROCEDURES? ARE RECORDS/LOGS OF WRITTEN PROCEDURES CORRECT AND IN GOOD ORDER? COMMENTS: (List Records Reviewed: Specify Types/Dates/Findings) Record Date Findings Version: 10/12/2017 9

10 REWORK PROGRAM DOES THE FIRM HAVE A REWORK PROGRAM? COMMENTS: SANITIZNG FOR RENTAL EQUIPMENT DOES THE FIRM HAVE A SANITIZING PROCEDURE AND POLICY FOR EQUIPMENT BROUGHT IN FROM RETAIL? COMMENTS: SUMMARY OF CURRENT FINDINGS AND MANAGEMENT RESPONSE WAS A NOTICABLE OF INSPECTIONAL OBSERVATIONS, FORM 483, ISSUED FOR OBJECTIONABLE CONDITIONS? IF A 483 WAS ISSUED, WHAT WILL THE FIRM DO TO CORRECT THE OBJECTIONABLE CONDITIONS AND WHEN? DID THE FIRMS MANAGEMENT REFUSE TO CORRECT THE OBJECTIONABLE CONDITIONS? WERE SAMPLES COLLECTED? DESCRIBE SAMPLES COLLECTIONS: ATTACHMENTS: ATTACHMENTS AND EXHIBITS EXHIBITS: ADDITIONAL INFORMATION: SIGNATURE AND DATE DATE: INVESTIGATORS PRINTED NAME AND TITLE: INVESTIGATORS SIGNATURE: INVESTIGATORS BADGE NUMBER: SUPERVISORS PRINTED NAME AND TITLE: SUPERVISORS SIGNATURE: ENDORSEMENT/CLASSIFICATION DATE REPORT ENTERED INTO e-saf: DATE ORIGINAL REPORT SENT TO FDA: TYPE OF ACTION INDICATED: Choose an item. HOW SENT TO FDA? Electronically & FedEx/UPS TRACKING NUMBER: ADDITIONAL COMMENTS Version: 10/12/