FDA Inspection 972342 — Velocity Pharma LLC
The FDA completed an inspection of Velocity Pharma LLC on May 18, 2016 in Melville, 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
- May 18, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Melville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1629 | 21 CFR 211.130(a) | Prevention of cross contamination, mix-ups |
| 1636 | 21 CFR 211.130(e) | Packaging line inspection before use |
| 1637 | 21 CFR 211.130(e) | Packaging line inspection after use |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4326 | 21 CFR 211.122(g)(2) | Electronic or electromechanical equipment |