FDA Inspection 725633 — The Estee Lauder Inc.
The FDA completed an inspection of The Estee Lauder Inc. on May 25, 2011 in Melville, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 25, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Melville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |
| 4378 | 21 CFR 211.188(b)(2) | Identity of major equipment and lines used |