1035213
Eau Zone Huiles & Fragrances Lee — FEI 3003629010
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 15, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Montreal (Canada)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1223 | 21 CFR 211.67(b)(5) | Cleaning SOPs/equipment protection |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 3604 | 21 CFR 211.160(b)(1) | Determination of conformance |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4345 | 21 CFR 211.160(b)(1) | Samples (various types) representative, identified properly |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |