FDA Inspection 1246567 — AJENAT PHARMACEUTICALS LLC
The FDA completed an inspection of AJENAT PHARMACEUTICALS LLC on August 16, 2024 in Largo, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 16, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Largo, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1938 | 21 CFR 211.167(c) | Controlled release dosage form testing |
| 22779 | FDCA 503B(b)(2)(A) | All inclusive product report, not submitted |
| 22787 | FDCA 503B(a)(10)(A) | Drug product labels, fails to include |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |