Updated January 18, 2017
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In-Person Ways to Avoid Form 483 Observations and Warning Letters - MDDI
- - original post follows below - -
Seven Strategies for Avoiding a 483: 'via Blog this'
"What a 483 is — and isn’t. After inspecting a food, drug, medical device, or biologic establishment, FDA prepares a written report of its inspection findings, following a debriefing. This report is intended primarily for internal FDA use and is not provided to the inspected institution at the conclusion of the on-site visit."A nice, quick and easy primer on 483s.
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