FDA Inspection 1191048 — AJES Pharmaceuticals, LLC
The FDA completed an inspection of AJES Pharmaceuticals, LLC on November 21, 2022 in Copiague, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 21, 2022
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Copiague, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15547 | 21 CFR 111.260(g) | Batch record - results; monitoring |
| 15681 | 21 CFR 111.315(d) | Standard reference materials; criteria for selecting |
| 15753 | 21 CFR 111.210(b) | Master manufacturing record - list components |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |