Recent FDA Inspection Findings and Trends

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Nicholas Parrish
6 years ago
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which are related to any inspection by an official agency shall be sent to the EBAA office and the Chair of the Accreditation Board within ten (10) business days of receipt.

1 Jan-09 Feb-09 Mar-09 Apr-09 May-09 Jun-09 Jul-09 Aug-09 Sep-09 Oct-09 Nov-09 Dec-09 Jan-10 Feb-10 Mar-10 Apr-10 May-10 Jun-10 Jul-10 Aug-10 Sep-10 Oct-10 Nov-10 Dec-10 Jan-11 Feb-11 Mar-11 Apr-11 May-11 Jun-11 Jul-11 Aug-11 Sep-11 Oct-11 Nov-11 Dec-11 Jan-12 Feb-12 Mar-12 Apr-12 6/21/2012 Recent FDA Inspection Findings and Trends Jennifer DeMatteo, MCM, CIC EBAA Director of Regulations and Standards EBAA Medical Standards B1.200 Inspections by Official Agencies Any written documentation of observations, findings, or results (including but not limited to Food and Drug Administration (FDA) Form 483) received by an eye bank which are related to any inspection by an official agency shall be sent to the EBAA office and the Chair of the Accreditation Board within ten (10) business days of receipt. The EBAA office and the Chair of the Accreditation Board shall be copied on all future related correspondence Regulatory Inspections Reported to the EBAA By Month Number of inspections without Observations Number of inpections with observations Regulatory Inspections By Region YTD Region Total No. of Regulatory Inspections Percentage Northeast % Southeast % Midwest % Southwest % West % Canada % TOTAL 110 1

Regulatory Inspections By Eye Bank Size Eye Bank Size 2009 2010 2011 2012 YTD Small 7 10 8 0 Medium 5 15 16 9 Large 10 17 9 4 Total 22 42 33 13 Regulatory Observations Number of Regulatory

2 Regulatory Inspections By Eye Bank Size Eye Bank Size YTD Small Medium Large Total Regulatory Observations Number of Regulatory Observations YTD 6% 6% 8% 4% 6% 1% 1% 3% 65% No 483 Issued 1 observation 2 observations 3 observations 4 observations 5 observations 6 observations 7 observations 8 observations Top Ten Observations Found During Eye Bank Inspections YTD 21 CFR Count Description Procedures Quality Program Environmental Controls & Monitoring Donor Eligibility Records Process Validation Donor Eligibility Procedures Storage Receipt and Distribution Reporting Equipment (a) Procedures Procedures appropriate to meet core CGTP requirements for all steps that you perform in the manufacture of HCT/Ps were not established, maintained, defined, documented, implemented, followed, reviewed, revised. Specifically, * 2

1271.180(a) Procedures SOPM lacked procedures for: Adverse reaction reporting Error and accident reporting (HCT/P deviations) Archived specimens Procedure for testing both infant donor and mother

180(a) Procedures Procedures were not followed: Environmental monitoring to validate processing was done in a way to prevent contamination.

Gloves & gowns not worn when handling tissue per SOP Record retention Aseptic technique Supervisory approval of SOP variance 1271.180 Procedures SOP Maintenance SOPs are not kept up to date.

3 (a) Procedures SOPM lacked procedures for: Adverse reaction reporting Error and accident reporting (HCT/P deviations) Archived specimens Procedure for testing both infant donor and mother Validation of insulated transport boxes Receipt, storage and release of ocular tissue for research & education Physical exam of ocular donors (a) Procedures Procedures were not followed: Environmental monitoring to validate processing was done in a way to prevent contamination. Dates of training completion is not recorded on training record per SOP. Entries in cleaning log and environmental culture documentation was not corrected per procedure. Gloves & gowns not worn when handling tissue per SOP Record retention Aseptic technique Supervisory approval of SOP variance Procedures SOP Maintenance SOPs are not kept up to date. SOP for lab excision doesn t reflect current practice states LFH and excisions are done in a clean room (b) Review and Approval SOP Manual doesn t contain documented approval of procedures by the director. 2 findings Establishment & Maintenance of a Quality Program A quality program which addresses all of the core CGTP requirements, appropriate for the HCT/Ps manufactured and the manufacturing steps performed, has not been established, maintained, defined, documented, implemented, followed, reviewed, revised. Specifically, *** 3

Quality Program Observations 1271.160 (a) General Expired SOPs were not removed 1271.160(b)2 Procedures No procedure for the approval of the validation and verification of software.

4 Quality Program Observations (a) General Expired SOPs were not removed (b)2 Procedures No procedure for the approval of the validation and verification of software. No procedure for monitoring distribution (b)3 Corrective Actions No CA s for missing recipient information No CA for incomplete autopsy findings No CA for incomplete plasma dilution sections CA for complaint about melted ice was not implemented. Quality Program Observations (b)6 HCT/P Deviations No investigation when med/soc history SOP was not followed Investigation of error in marking pre-transfusion blood samples did not correct written specifications for adequacy of specimens or include test inserts and lab procedures Investigation of inadequate sterilization did not include CA s review of time/temp before use of equipment and change in SOP (c) Audits Periodic quality audits were not performed, specifically audits of establishment performing DRAI. (x2) No RCA or follow-up audit performed for issues with storage/monitoring of supplies or tissue found without a donor number. Periodic audit by direct observation not performed Environmental Controls and Monitoring (a) Environmental Control Didn t provide adequate temperature control. No explanation or CA for out-of-range temperatures (c) Environmental Monitoring No monitoring of environmental conditions for microorganisms before, during, and after processing corneas. (x2) No rationale for 25 CFU threshold for settling plates within LFH or used for touch plates. Microbial monitoring doesn t specify which organisms warrant investigation Environmental Controls and Monitoring (d) Records Documentation of environmental controls/monitoring was not maintained ATTEST documentation not maintained. 14 of 16 biological indicators for adequacy of sterilization of processing equipment were read at less than the hour required. SOP on biological contamination control directs sampling take place according to two diagrams, which aren t included in the procedure. 4

1271.55 - Donor Eligibility Records 1271.

55(b) Summary of Records Accession numbers for specimens not kept in a logbook Documentation of name/address of communicable disease testing lab not maintained 55(d) Record Retention Requirements

5 Donor Eligibility Records (a) Accompanying Records No DE or slit lamp evaluation documentation accompanied tissue - EB contracts with another facility for evaluation and release of tissue (b) Summary of Records Accession numbers for specimens not kept in a logbook Documentation of name/address of communicable disease testing lab not maintained Donor Eligibility Records (d) Record Retention Requirements Records were not retained for 10 years (x3) Third party records used for DE were destroyed 6 months after DE was determined and quality reviews were complete. Records were purged after DE determined and tissues were distributed. Deleted with DE document and failed to retain a paper record in the donor file. Contracted establishment purges all paper, computer, and tape records w/in 30 days. No documentation to explain why donor was accepted when there were possible contraindications DE records were not accurate, indelible, and legible Numerous (9 of 25) discrepancies between recording and hard copy questionnaire Process Validation Procedures to validate and approve processes that cannot be fully verified by inspection and tests were not established, defined, and documented. Specifically *** Process Validation EK precuts were not validated to ensure no microbial contamination before, during, and after cutting corneas (x3) Tissue transfer from one storage chamber/media vial to another is not validated. No SOP exists describing steps for freezing scleral tissue until tissue is thawed and fully processed/preserved. Validation of tissue cultures doesn t assess antibiotics in media to prevent false positive cultures. A validated process that was changed was not reviewed, evaluated, and revalidated, Specifically, the electronic system used for labels was not revalidated. 5

6 Donor Eligibility Procedures Procedures for all steps in testing, screening, and DE determination were not established, maintained, defined, documented, implemented, followed, reviewed, revised. Specifically, *** Distribution SOP mentions a form and not the software database currently used. DE procedures were not followed (x3) Tissues from a donor with bacteremia and another with a pig valve were released. Didn t follow Physician Consultation procedure and used consults from a 3 rd party MD who was not involved in the donor s care to support acceptance of the donor. Abbreviated med/soc questions Corneas recovered despite military travel and sepsis documentation Donor Eligibility Procedures (d) Departures from procedures No justification recorded for deviating from donor eligibility procedures. A determination that a BPD did not increase the risk of disease transmission was not made by a responsible person prior to distribution. Specifically, DRAI indicates that donor received blood products prior to death, but there is no further documentation or medical record review. There was verbal information regarding 1000 ml NS, but no medical records were obtained to verify volume Storage (b) Temperature Temperature verification of insulated eye box not performed (d) Corrective Action No report or CA taken when refrigerator temperature were out of range. No documentation of CA when corneal shipment was delayed due to winter weather no assurances that temperature was maintained (e) Acceptable Temperature Limits Storage temperature for media refrigerator not recorded for one week. Recorded storage temperatures not routinely reviewed to ensure temps are w/in acceptable limits. No documented comparison between digital display, temp chart recorder, and manual thermometer per SOP. No scientific documentation for storage at -70 C Receipt and Distribution (a) Receipt - No documentation of eye tissue inspection & condition of returned tissues for damage or contamination (c) Availability for Distribution Tissues sent out for processing before distribution did not have a review of manufacturing and tracking records prior to release. Release criteria not verified before tissue made available for distribution. Documentation shows tissue was shipped on March 2 but DE determination was Mar 3 due to paper and electronic documentation (d) Packaging and Shipping - no validation of insulated transport boxes (e) Procedures Procedure does not specify quantity of ice to place in shipping container (f) Return to inventory Neither the Procedure nor Assessment Form mentions that a media color change may be indicative of bacterial contamination. 6

1271.200 - Equipment 1271.350 - Reporting 1271.

read at the correct time, often days later. No instructions for calculating acceptable centrifuge calibration ranges 1271.

7 Equipment Reporting (b) Procedures and schedules Dates not recorded on temperature monitoring charts Biological indicator results recorded at different time intervals than SOP requires; documentation indicates not read at the correct time, often days later. No instructions for calculating acceptable centrifuge calibration ranges (e) Records SOP states that LFH cleaned once a week and before and after each use but no documentation found for cleaning before processing use on 3 occasions. Failure to document reasons and troubleshooting for sterilization cycle failure. Failure to document centrifuge calibration. Adverse reactions SOP did not include notification and reporting HCT/P deviations were not reported to the FDA (x2) Temperature control deviation Shipment delay Error/accidents not detected prior to tissue release were not reported to the state Med/soc questions were unanswered. Deviations related to distributed HCT/Ps were not investigated after a shipment delay. Less Frequent 483 Observations (c) Manufacturing Agreements Contracted donor screening but did not verify that scanned questionnaire matched original form or that the interview matches the audiotape Personnel SOP doesn t delineate the person responsible for each procedure. SOPM doesn t contain protocol for periodic review by user personnel no documented review in training file of QA personnel. No training documentation on updated P&Ps for out of town technicians. Personnel have not been trained as necessary to perform their assigned responsibilities. Multiple instances of failure to log tissue recoveries and no training documentation for the use of this form in training files Facilities Facility did not provide adequate plumbing with hot water. FDA Form 483 Observations Supplies and Reagents Supplies / reagents not stored per manufacturers instructions (x2) Supplies / reagents were used before they were verified to meet specifications (x2) Expired reagent used to clean BSC prior to tissue processing; temperature storage issue Processing and Process Controls Technician contaminated sterile forceps with wet autoclaved turbine box during corneal processing Labeling Controls Discrepancy found between donor ID number and cornea ID number Labels on coolers missing a label that they contain human tissue Package insert didn t include all required information 7

1271.270 Records No agreement with processing eye bank listing names, addresses, services, and responsibilities of that establishment.

8 Records No agreement with processing eye bank listing names, addresses, services, and responsibilities of that establishment. SOP not followed regarding timeframes of reporting and investigation of NCR, lacked dates and signatures, NCRs without root cause identified or further investigation conducted Tracking Tracking system did not document disposition of each tissue. Tissue discard log didn t account for 15 discarded corneas; they were instead documented within each donor s file Complaint File Complaints received were not maintained in a file designated for complaints. Complaint file contained insufficient info for review & evaluation no RCA performed; surgeon was not notified Complaints were not reviewed and evaluated to determine if complaint was related to a deviation or AR. No investigation documented for complaint related to an AR, and no Medical Director review/evaluation Donor Eligibility Determination No SOP for DE determination and delegated authority Med/soc history forms screen wrong time frame for receipt of human-derived pituitary growth hormone. Pediatric donor suitability questions asked of mother but not donor regarding sexual history and incarceration Quarantine Quarantined tissue not labeled as required Tissue shipped for processing was not shipped in quarantine Donor Screening and Donor Testing A second DRAI performed but not maintained by firm or contractor. Donors with risk factors were not determined to be ineligible; specifically hepatitis history and bovine heart valve. RPR testing done on plasma samples stored longer than 48 hrs. Less Frequent Observations Registration Changes Failure to notify State DOH of changes in registration information (address change) within 30 days Bloodborne Pathogens Failure to label storage area with the universal biohazard sign. 8

APPLICATION FOR SITE INSPECTION Eye Bank Association of America

APPLICATION FOR SITE INSPECTION Eye Bank Association of America Complete this application to begin the process for inspection and accreditation by the Eye Bank Association of America (EBAA). See the EBAA