FDA Inspection
ANI Pharmaceuticals, IncANI Pharmaceuticals, Inc – FDA Inspection, Aug 27, 2026
Record Details
This FDA Inspection record concerns ANI Pharmaceuticals, Inc, with an inspection on August 27, 2026, issued by the New Jersey District Office, covering human drugs.
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ID · bc10ec8a-fcda-4244-aa3c-af1073de0974
Inspection Facts
- Inspection number
- 1288062
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 314.80(c)(1)(ii)Failure to investigate serious, unexpected events
- 21 CFR 314.80(j)Failure to maintain records
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