FDA Inspection 777706 — Estee Lauder Cosmetics Ltd.
The FDA completed an inspection of Estee Lauder Cosmetics Ltd. on January 26, 2012 in Scarborough. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 26, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Scarborough (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1545 | 21 CFR 211.125(c) | Label reconciliation discrepancies evaluation/investigation |