FDA Inspection 762085 — Velocity Pharma LLC
The FDA completed an inspection of Velocity Pharma LLC on January 26, 2012 in Melville, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 26, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Melville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15733 | 21 CFR 111.365 | Manufacturing operations - prevent contamination |
| 15780 | 21 CFR 111.415 | Fill, assemble, package, label - master record |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |