FDA Inspection
Aprecia Pharmaceuticals LLCAprecia Pharmaceuticals LLC – FDA Inspection, Mar 21, 2025
Record Details
This FDA Inspection record concerns Aprecia Pharmaceuticals LLC, with an inspection on March 21, 2025, issued by the Cincinnati District Office, covering human drugs.
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ID · 47a24c0c-b6f4-4239-a0a2-56c8eeb394e0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1264269
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.84(d)(2)Component identification test
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Other FDA inspections of Aprecia Pharmaceuticals LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 23, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 23, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 3, 2017 | Not classified | Cincinnati District Office |
Other documents for Aprecia Pharmaceuticals LLC
- FDA Inspection 1092472 - 2019-05-23
- FDA Inspection 1054779 - 2018-05-23
- FDA Inspection 1030116 - 2017-10-03
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