FDA Inspection 1038726 — The Estee Lauder Inc.
The FDA completed an inspection of The Estee Lauder Inc. on January 26, 2018 in Melville, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 26, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Melville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 8935 | FDCA 760(b)(1) | Failure of responsible person to report AE (non-RX Drug) |