FDA Inspection 676249 — Venus Pharmaceuticals International, Inc.
The FDA completed an inspection of Venus Pharmaceuticals International, Inc. on August 19, 2010 in Hauppauge, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 16 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 19, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Hauppauge, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15481 | 21 CFR 111.23(b) | Records - cleaning, pest control |
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15582 | 21 CFR 111.155(e) | Components - contamination, deterioration, mix-ups |
| 15586 | 21 CFR 111.155(e) | Components - contamination, deterioration, mix-ups |
| 15665 | 21 CFR 111.303 | Written procedures - tests, examinations; specifications met |
| 15732 | 21 CFR 111.365(a) | Conditions, controls -protect; microorganisms, contamination |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16046 | 21 CFR 111.503 | Written procedures returned dietary supplement investigation |