FDA Inspection 764329 — Venus Pharmaceuticals International, Inc.
The FDA completed an inspection of Venus Pharmaceuticals International, Inc. on January 20, 2012 in Hauppauge, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 20, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Hauppauge, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15590 | 21 CFR 111.160(c)(1) | Packaging - quarantine; samples |
| 15596 | 21 CFR 111.160(c)(3) | Packaging - quality control; approve, release |
| 15597 | 21 CFR 111.160(c)(3) | Labels - quality control; approve, release |
| 15665 | 21 CFR 111.303 | Written procedures - tests, examinations; specifications met |
| 15702 | 21 CFR 111.320(b) | Examination, testing; scientifically valid |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15986 | 21 CFR 111.123(b)(2) | Quality control - batch, product specifications |