FDA Inspection
Areva Pharmaceuticals IncAreva Pharmaceuticals Inc – FDA Inspection, Sep 11, 2025
Record Details
This FDA Inspection record concerns Areva Pharmaceuticals Inc, with an inspection on September 11, 2025, issued by the Detroit District Office, covering human drugs.
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ID · f2e9159c-fa3a-4516-b76c-50d51e85201d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1282336
- FDA center
- Human Drugs
- Project area
- Postmarketing Surveillance and Epidemiology: Human Drugs
FDA Citations
3- 21 CFR 314.81(b)(2)Timely submission
- 21 CFR 314.80(c)(2)Late submission of annual safety reports
- 21 CFR 314.80(b)Failure to develop written procedures
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