FDA Inspection 1278978 — Pharbest Pharmaceuticals, Inc.
The FDA completed an inspection of Pharbest Pharmaceuticals, Inc. on Sep 15, 2025 in Farmingdale, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 15, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Farmingdale, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 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 |
| 1957 | 21 CFR 211.180(e)(2) | Review of problem drugs |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4304 | 21 CFR 211.68(b) | Written record not kept of program and validation data |