FDA Inspection 1048617 — Pharbest Pharmaceuticals, Inc.
The FDA completed an inspection of Pharbest Pharmaceuticals, Inc. on April 18, 2018 in Farmingdale, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 18, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Farmingdale, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15899 | 21 CFR 111.83(b)(1) | Reserve sample container-closure contamination,deterioration |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |