FDA Inspection 735593 — Venus Pharmaceuticals International, Inc.
The FDA completed an inspection of Venus Pharmaceuticals International, Inc. on July 12, 2011 in Hauppauge, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 12, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Hauppauge, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1125 | 21 CFR 110.40(a) | Materials and workmanship |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15582 | 21 CFR 111.155(e) | Components - contamination, deterioration, mix-ups |
| 15710 | 21 CFR 111.325(b)(2)(i) | Document; laboratory methodology followed |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 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 |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16037 | 21 CFR 111.605 | Records - keep: 1 year, 2 years |