FDA Inspection 1264269 — Aprecia Pharmaceuticals, LLC
The FDA completed an inspection of Aprecia Pharmaceuticals, LLC on Mar 21, 2025 in Mason, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 21, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mason, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |