988788
LVMH Fragrance Brands — FEI 1000495086
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 23, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Beauvais (France)
Citations
| ID | CFR | Description |
|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4323 | 21 CFR 211.115(a) | Reprocessing procedures lack steps to be taken |
| 4409 | 21 CFR 211.194(a)(4) | Data secured in course of each test |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |