Transcript Regina Barrell, Consumer Safety Officer, FDA
Top 10 Medical Device Citations
Regina A. Barrell Food and Drug Administration Office of Regulatory Affairs Office of Enforcement and Import Operations Division of Enforcement
QSIT Approach to Inspections
Level 1 – Abbreviated – 2 subsystems; Corrective and Preventive Actions (CAPA) plus Production and Process Controls (P & PC) or Design Controls.
QSIT Approach to Inspections
Level 2 – Comprehensive – 4 major subsystems; Management Controls, Design Controls, CAPA and P & PC.
QSIT Approach to Inspections
Level 3 – Compliance Follow-Up – Special – For Cause – Special – Risk Based Work Plan As directed by inspectional guidance and elements of QSIT.
QSIT Approach to Inspections
Compliance Follow-Up, For Cause and Risk Based Work Plan are dictated by the previous FDA-483 findings and other regulatory information and may differ from the typical QSIT approach.
2012
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2.
3.
4.
5.
820.100(a) – Corrective and Preventive Action (Procedures) 820.198(a) – Complaint procedures 803.17 – Written MDR procedures 820.100(b) – Corrective and Preventive Action (Documentation) 820.50 – Purchasing Controls
2012
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820.75(a) – Process validation 820.90(a) – Control of non-conforming product 8.
9.
820.30 (i) – Design change procedures 820.198 (c) – Complaint investigation 10.
820.181 – Device master record not maintained
1 2 3 4 5 Total Turbo Citations vs.
2012 Citations Total 820.100(a) 2012 820.100(a) 803.17
820.100(b) 820.198(a) 820.198(a) 803.17
820.100(b) 820.75(a) 820.50
6 7 8 9 10 Total Turbo Citations vs. 2012 Citations Total 820.22
2012 820.75(a) 820.22
820.30(i) 820.50
820.90(a) 820.30(i) 820.198(c) 820.30(a) 820.181
TOP FIVE FDA 483 CITATIONS FOR MEDICAL DEVICE FIRMS
Number One
21 CFR 820.100(a) Procedures for corrective and preventive action have not been [adequately] established.
21 CFR 820.100(a)
For example: Failure to analyze processes, service records, quality audit reports, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product;
21 CFR 820.100(a) contd.
Cause of nonconformities relating to product, processes and the quality system are not investigated; Actions needed to correct and prevent recurrence of nonconforming product or other quality problems are not identified.
TOP FIVE FDA 483 CITATIONS FOR MEDICAL DEVICE FIRMS
Number Two
21 CFR 820.198(a) Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been [adequately] established.
21 CFR 820.198(a) For example: Complaints are not processed in a uniform or timely manner; are not documented; or have not been evaluated for MDR applicability.
TOP FIVE FDA 483 CITATIONS FOR MEDICAL DEVICE FIRMS
Number Three
21 CFR 803.17
Written MDR procedures have not been [developed] [maintained] [implemented].
21 CFR 803.17
For example: Your firm’s Complaint Handling procedure states that complaints shall be reviewed for MDR reporting per 21 CFR 803, however there are no additional MDR procedures.
21 CFR 803.17 contd.
For example: Your procedure does not contain a standardized process for determining when an event meets the criteria for MDR. There are no instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner.
TOP FIVE FDA 483 CITATIONS FOR MEDICAL DEVICE FIRMS
Number Four
21 CFR 820.100(b) Corrective and preventive action activities and/or results have not been [adequately] documented.
TOP FIVE FDA 483 CITATIONS FOR MEDICAL DEVICE FIRMS
Number Five
21 CFR 820.50
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been [adequately] established.
21 CFR 820.50
For example: Of 11 supplier records reviewed, 4 were not evaluated or included on your firm’s approved supplier list.
21 CFR 820.50 contd.
For example : Your supplier, which was used to fill ampoules, was disqualified due to quality issues but was left on your approved suppliers list because the supplier was still approved for other services.
FDA Enforcement Statistics Summary Fiscal Year 2012 Seizures Injunctions Warning Letters Recall Events Recalled Products Debarments 8 17 4,882 4,075 9,469 20
CDRH Enforcement Statistics Summary Fiscal Year 2012 Seizures Injunctions Warning Letters Recall Events Recalled Products 1 2 210 1,190 2,475
2 1 1
CDRH Seizures By Fiscal Year
2 1 1 0 2007 0 2008 2010 2011 2012
4 3 2 4 1 0 2007
CDRH Injunctions By Fiscal Year
1 2008 2 2010 0 2011 2 2012
CDRH Warning Letters By Fiscal Year
225 200 175 150 125 100 75 50 25 0 155 2007 152 2008 204 2010 175 2011 210 2012
Total Recall Events - CDRH Fiscal Year 2007 - 2012
1400 1200 1000 800 600 400 200 0 664 831 876 1,271 1,190 2007 2008 2010 2011 Class I, II and III 2012
Total Recall Products - CDRH Fiscal Year 2007 - 2012
3500 3000 2500 2000 1500 1000 500 0 1,279 2007 2,472 2,634 2008 3,211 2010 2011 Class I, II and III 2,475 2012
CDRH Recalls – All Classes Fiscal Year 2007 - 2012
3500 3000 2500 2000 1500 1000 500 0 2,472 1,279 664 831 2007 2,634 876 2008 2010 Events 3,211 1,271 1,190 2011 Products 2,475 2012
Recalls: Definition of Class I Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
CDRH Class I Recalls – Fiscal Year 2007 - 2012
450 400 350 300 250 200 150 100 50 0 26 45 2007 14 131 2008 49 334 2010 Events 50 427 57 124 2011 Products 2012
Recalls: Definition of Class II
Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
CDRH Class II Recalls – Fiscal Year 2007 - 2012
3000 2500 2000 1500 1000 500 0 2,178 1,102 540 709 2007 2,208 753 2008 2010 Events 2,665 1,151 2011 Products 2,210 1,043 2012
Recalls: Definition of Class III
Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
CDRH Class III Recalls – Fiscal Year 2007 - 2012
180 160 140 120 100 80 60 40 20 0 163 98 132 108 74 92 2007 70 119 90 141 2008 2010 Events 2011 Products 2012
Root-Cause Categories FY 2010 – FY 2012
11% 19% 49% 15% 6% Design Process Control Packaging/Labeling Change Control Material/Component