FDAzilla offers a specialized search tool that makes it possible to search for Form 483 observations issued by the FDA.
One possible use of the search tool is to get a listing of Form 483s issued to companies in a particular country, for example, the search results of form 483 observations issued to companies in India. Just alter your search keywords to view different results.
Related reading: Compliance Remediation for Pharmaceutical Manufacturing: A Project Management Guide for Re-establishing FDA Compliance
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An extensive library of 483 citation summaries from the FDA. Match the case with the corresponding 21 CFR 211 reference. Used 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.Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
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2 comments:
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