FDA Inspection 888236 — AJES Pharmaceuticals, LLC
The FDA completed an inspection of AJES Pharmaceuticals, LLC on July 18, 2014 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
- July 18, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Copiague, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15351 | FDCA 761(b)(1) | No AE report made (dietary supplement) |
| 15567 | 21 CFR 111.260(l)(4) | Batch record - approved, released, rejected |
| 15702 | 21 CFR 111.320(b) | Examination, testing; scientifically valid |
| 15734 | 21 CFR 111.360 | Manufacturing operations - sanitation |
| 15800 | 21 CFR 111.560(a)(2) | Product complaint - quality control investigate |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 16072 | 21 CFR 111.35(b)(3) | Instruments, controls; calibrate date, reference std, method |