Monday, October 20, 2008

More FDA 483 Resources - Comments and Pearls from Validation Online

Check this out. More resources on how to apply learnings gleaned from FDA 483s. This particular resource can be found on the website. In particular, there's a nice collection of "cGMP FDA 483 COMMENTS." Here you'll find over 100 FDA 483 topics that cover a 483 issue with associated comments, tips, and recommendations. Validation Online says, "Some of the problems listed below cost companies million of dollars to find and rectify."

Previous FDA 483 Posts:
The Health, Drug, Prescription, and GMP Supersite: FDA 483 Inspectional Observations - learn from these examples

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