FDA Enforcements for 2011 - RAPS article on FDA Inspections and Enforcements

sreenu927

Quite Involved in Discussions
#1
Hi,

There is a RAPS article on FDA Inspections and Enforcements that summarizes the 2011 FDA Warning Letters, top ten deficiencies for Drugs, Devices, and number of domestic and foreign inspections, etc..

See attached presentation.

Top ten medical device deficiencies according to FDA:
1. CFR 820.100(a) Procedures for corrective and preventive action have not been [adequately] established.
2. CFR 803.17 Written MDR procedures have not been [developed] [maintained] [implemented].
3. CFR 820.198(a) Complaint handling procedures for [receiving] [reviewing] [evaluating] complaints have not been [established] [defined] [documented] [completed] [implemented].
4. CFR 820.100(b) Corrective and preventive action activities and/or results have not been [adequately] documented.
5. 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.
6. CFR 820.22 Quality [audits][reaudits] have not been performed.
7. CFR 820.22 Procedures for quality audits have not been [adequately] established.
8. CFR 820.30(a) Procedures for design control have not been established.
9. CFR 820.30(i) Procedures for design change have not been [adequately]
established.
10. CFR820.50 Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been [adequately] established.

Regards,
Sreenu
 

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