Top 10 Device Observations in 2011 (Citations made in Form 483s)
The FDA increased the number of inspections in 2011 to a record level. This resulted in a new level of Form 483 Inspectional Observations issued to medical device (and food) firms (distributors/manufacturers/importers etc.). The FDA released the top 10 medical device observations at a recent Regulatory Affairs Professional Society breakfast. The top 10 observations for 2011 were:
- 21 CFR 820.100(a) – Procedures for Corrective and Preventative Action (CAPA) have not been adequately established;
- 21 CFR 803.17 – Written Medical Device Report (MDR) procedures have not been developed/maintained/implemented;
- 21 CFR 820.198(a) – Complaint handling procedures for receiving/reviewing/evaluating complaints have not been established/defined/documented/completed/implemented;
- 21 CFR 820.100(b) – Corrective and Preventative Action activities and/or results have not been adequately documented;
- 21 CFR 820.75(a) – A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures;
- 21 CFR 820.22 – Quality audits/reaudits have not been performed;
- 21 CFR 820.22 – Procedures for quality audits have not been adequately established;
- 21 CFR 820.30(a) – Procedures for design control have not been established;
- 21 CFR 820.30(i) – Procedures for design change have not been adequately established;
- 21 CFR 820.20 – Management with executive responsibility has not ensured that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization.
As the new year begins it is important to ensure that any all SOPs and quality systems are up to date. Hiring an outside consultant at this stage, who can preventatively ensure that the most common errors are avoided, can help save a firm money in responding to a Form 483 or Warning Letter.
A list of the top 10 Drug observations is also available by e-mail request.
- No comments Posted in: Inspections (483s and Warning Letters), Medical Device News (FDA) Tags: 1 CFR 820.22, 21 CFR 803.17, 21 CFR 820.100(a), 21 CFR 820.100(b), 21 CFR 820.198(a), 21 CFR 820.20, 21 CFR 820.30(a), 21 CFR 820.30(i), 21 CFR 820.75(a), 483 Response, FDA Inspection, FDA Recall, Form 483, Warning Letter
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