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21 CFR Citation Lookup: Form 483 Observations by Section

Enter a 21 CFR section or a topic to see how often FDA investigators cite it on Form 483, at how many facilities, and the latest inspections that cited it. No sign-up.

What this lookup covers

Every regulation section in the inspection citations FDA publishes on its Data Dashboard: drug CGMP (21 CFR 211), device quality system (21 CFR 820), food (21 CFR 117), clinical research and more.
A citation is one observation an investigator lists on Form FDA 483 at the end of an inspection, tagged with the regulation it relates to.
Each result links to the facilities cited, their FDA inspection history, and the regulation text on eCFR.

See the most-cited Form 483 sections, search citations by company with the FDA 483 search, or link straight to a lookup: https://www.regdatalab.com/tools/cfr-lookup?q=211.192.

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