FDA Inspection 1027659 — Estee Lauder Cosmetics Ltd.
The FDA completed an inspection of Estee Lauder Cosmetics Ltd. on September 29, 2017 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
- September 29, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Scarborough (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1393 | 21 CFR 211.103 | Yield calculations not verified by 2nd person |
| 3573 | 21 CFR 211.101(b) | Measured components for manufacturing |
| 4379 | 21 CFR 211.188(b)(1) | Dates not included for each significant step |