FDA-Regulated Industry

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Week of September 30th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

The FDA posted 13 warning letters this week. A collection were from the Center for Tobacco Products. There was 1 warning letter issued to a PET firm, 1 to a device firm, and 1 to a compounding pharmacy. We cover all 3 in this post.

6 Features to Look for in FDA 483s

A challenge with interpreting 483s that are issued to firms other than your own is that 483s don’t provide the context for what occurred during the inspection and how the issues were identified. Thus, to evaluate the seriousness of a 483 and the potential for additional enforcement action, I ask the following questions.