FDA Inspection 590096 — Cosette Pharmaceuticals, Inc.
The FDA completed an inspection of Cosette Pharmaceuticals, Inc. on Jun 18, 2009 in South Plainfield, NJ. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 15 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 18, 2009
- Fiscal Year
- 2009
- 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 |
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1722 | 21 CFR 211.134(a) | Correct labels during finishing operations |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |