FDA Inspection 930773 — Pharbest Pharmaceuticals, Inc.
The FDA completed an inspection of Pharbest Pharmaceuticals, Inc. on Jun 8, 2015 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 8, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Farmingdale, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1796 | 21 CFR 211.80(d) | Identification of Each Lot in Each Shipment |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |