FDA Inspection 662123 — Cosette Pharmaceuticals, Inc.
The FDA completed an inspection of Cosette Pharmaceuticals, Inc. on May 17, 2010 in South Plainfield, NJ. 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
- May 17, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- South Plainfield, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4576 | 21 CFR 211.192 | No written record of investigation |