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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;
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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 • 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 • 820.75(a) – Process validation • 820.90(a) – Control of non-conforming product • 820.30 (i) – Design change procedures • 820.198 (c) – Complaint investigation • 820.181 – Device master record not maintained
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.
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.
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.
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.
