FDA Inspection 677232 — InvaGen Pharmaceuticals, Inc.
The FDA completed an inspection of InvaGen Pharmaceuticals, Inc. on Aug 27, 2010 in Hauppauge, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 27, 2010
- Fiscal Year
- 2010
- 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 |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |