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In the article, LeeAnn Rogus offers many tips. Here's just one of the many pearls of wisdom that's shared:
"The 15 days FDA gives a company to respond to a Form 483 inspectional observation has always existed, but the agency would usually let you have extra time. Not any more."Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
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You might also be interested in this GMP training aid: Inspection Detection, a 483-based training resource by SkillsPlus International Inc.
It has an extensive library of 483 citation summaries from the FDA. You can match the case with the corresponding 21 CFR 211 reference. Useful as a classroom training tool or for self-study, this training aid challenges the student to identify and justify the 21 CFR 211 reference that supports the 483 citation.
These really helped, thanks for the free tips!
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