Monday, September 6, 2010

FDA Form 483 Search Tool

Updated January 27, 2021

Links in the original post broke.


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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

You might also be interested in:

Inspection Detection - a GMP training game by SkillsPlus Intl Inc.
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.
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From SkillsPlus International Inc.