FDA Inspection 897811 — Estee Lauder Cosmetics Ltd.
The FDA completed an inspection of Estee Lauder Cosmetics Ltd. on September 19, 2014 in Scarborough. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 19, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Scarborough (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 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 |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |