1025064
Orean Personal Care Ltd — FEI 3010999645
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 8, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cleckheaton (United Kingdom)
Citations
| ID | CFR | Description |
|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 3610 | 21 CFR 211.160(b)(3) | Drug product sample |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |