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:

  1. 21 CFR 820.100(a) – Procedures for Corrective and Preventative Action (CAPA) have not been adequately established;
  2. 21 CFR 803.17 – Written Medical Device Report (MDR) procedures have not been developed/maintained/implemented;
  3. 21 CFR 820.198(a) – Complaint handling procedures for receiving/reviewing/evaluating
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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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