FDA Inspection 888588 — Pharbest Pharmaceuticals, Inc.
The FDA completed an inspection of Pharbest Pharmaceuticals, Inc. on July 11, 2014 in Farmingdale, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 11, 2014
- Fiscal Year
- 2014
- 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 |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 3545 | 21 CFR 211.44 | Adequate lighting not provided |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |