FDA Inspection 1253074 — AJES Pharmaceuticals, LLC
The FDA completed an inspection of AJES Pharmaceuticals, LLC on December 9, 2024 in Copiague, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 9, 2024
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Copiague, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15533 | 21 CFR 111.255(c) | Batch record - follow master |
| 15681 | 21 CFR 111.315(d) | Standard reference materials; criteria for selecting |
| 15905 | 21 CFR 111.90(a)(1) | Reprocessed - rejected dietary supplement |
| 22814 | 21 CFR 111.553 | Written procedures - follow; product complaint |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |