FDA Inspection 684166 — AJES Pharmaceuticals, LLC
The FDA completed an inspection of AJES Pharmaceuticals, LLC on October 4, 2010 in Copiague, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 4, 2010
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Copiague, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15582 | 21 CFR 111.155(e) | Components - contamination, deterioration, mix-ups |
| 15710 | 21 CFR 111.325(b)(2)(i) | Document; laboratory methodology followed |
| 15737 | 21 CFR 111.210(h)(5) | Corrective action plans |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 16071 | 21 CFR 111.35(b)(3) | Documentation - instruments, controls; calibrations |