FDA Inspection 1190336 — Pharbest Pharmaceuticals, Inc.
The FDA completed an inspection of Pharbest Pharmaceuticals, Inc. on November 10, 2022 in Farmingdale, 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 10, 2022
- Fiscal Year
- 2023
- 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 |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |