FDA Inspection 1046683 — AJES Pharmaceuticals, LLC
The FDA completed an inspection of AJES Pharmaceuticals, LLC on March 29, 2018 in Copiague, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 29, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Copiague, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15922 | 21 CFR 111.95(b)(3) | Documentation - ensure specifications met |