FDA Inspection 1155111 — AJES Pharmaceuticals, LLC
The FDA completed an inspection of AJES Pharmaceuticals, LLC on October 14, 2021 in Copiague, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- October 14, 2021
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Copiague, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15681 | 21 CFR 111.315(d) | Standard reference materials; criteria for selecting |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15922 | 21 CFR 111.95(b)(3) | Documentation - ensure specifications met |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |