704306
Kenvue Brands LLC — FEI 2510184
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 9, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fort Washington, PA (United States)
Citations
| ID | CFR | Description |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4576 | 21 CFR 211.192 | No written record of investigation |