FDA Inspection 932607 — Apnar Pharma LLP
The FDA completed an inspection of Apnar Pharma LLP on July 10, 2015 in East Windsor, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 10, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- East Windsor, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15454 | 21 CFR 111.16 | Written procedures - pest control |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15899 | 21 CFR 111.83(b)(1) | Reserve sample container-closure contamination,deterioration |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |