FDA Inspection 646066 — Vertical Pharmaceuticals, LLC
The FDA completed an inspection of Vertical Pharmaceuticals, LLC on February 24, 2010 in Sayreville, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 24, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sayreville, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3562 | 21 CFR 211.56(c) | Written procedures lacking for use of pesticides etc. |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |