FDA Inspection 813447 — Velocity Pharma LLC
The FDA completed an inspection of Velocity Pharma LLC on January 11, 2013 in Melville, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 11, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Melville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1633 | 21 CFR 211.130(d) | Examination of packaging and labeling |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4399 | 21 CFR 211.186(b)(7) | Theoretical yield statement including percentages |