FDA Inspection 962200 — AJES Pharmaceuticals, LLC
The FDA completed an inspection of AJES Pharmaceuticals, LLC on March 9, 2016 in Copiague, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 9, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Copiague, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15352 | FDCA 761(b)(1) | No label copy submitted with AE report (dietary supplement) |
| 15469 | 21 CFR 111.20(c)(3) | Physical plant - separate areas for products |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15901 | 21 CFR 111.83(b)(3) | Reserve sample - retained |
| 16037 | 21 CFR 111.605 | Records - keep: 1 year, 2 years |