FDA Inspection 697223 — InvaGen Pharmaceuticals, Inc.
The FDA completed an inspection of InvaGen Pharmaceuticals, Inc. on Nov 10, 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 10, 2010
- Fiscal Year
- 2011
- 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 |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4349 | 21 CFR 211.160(b)(2) | In-process samples representative, identified properly |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |