Medical Device Sponsors - FDA Trends and Tips To Avoid 483s

Updated November 5, 2024

The original link broke

You might also be interested in this article by the same author, Carl Anderson:

The FDA 483 - https://carl1anderson.wordpress.com/wp-content/uploads/2009/03/the-fda-483.pdf

---  the original post follows below  ---

The Division of Bioresearch Monitoring, Office of Compliance, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration, released inspection statistics for the 2007 fiscal year. The statistics for the 40 Bioresearch Monitoring (BIMO) inspections of medical device sponsors showed serious concerns for compliance with good clinical practice (GCP) regulations. Author Carl Anderson explains the CDRH findings, identifies problem areas to avoid, and gives tips on how to avoid 483s, in his article, "Trends in FDA CDRH Bioresearch Monitoring Inspections." The following are the topics he covers in the article . . .

• About the Division of Bioresearch Monitoring Organization at CDRH
• Medical Device Sponsor Inspections
• Quality Systems in Clinical Trials
• Implications of BIMO Inspection Statistics - with a top 5 category list of deficiencies

Don't get caught flat-footed. Reading this article will help you steer clear of choppy waters, warnings, and 483s.

Related Posts:
More FDA 483 Resources - Comments and Pearls from Validation Online
FDA 483 Inspectional Observations - learn from these examples

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