Check this out. More resources on how to apply learnings gleaned from FDA 483s. This particular resource can be found on the Validation-Online.net 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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Monday, October 20, 2008
More FDA 483 Resources - Comments and Pearls from Validation Online
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