1234457
Orean Personal Care Ltd — FEI 3010999645
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 15, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cleckheaton (United Kingdom)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |