FDA Inspection 821197 — InvaGen Pharmaceuticals, Inc.
The FDA completed an inspection of InvaGen Pharmaceuticals, Inc. on March 8, 2013 in Hauppauge, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 8, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hauppauge, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |