FDA Inspection 938546 — The Estee Lauder Inc.
The FDA completed an inspection of The Estee Lauder Inc. on Aug 6, 2015 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). 14 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 6, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Melville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1163 | 21 CFR 211.28(b) | Habits of good sanitation & health |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4576 | 21 CFR 211.192 | No written record of investigation |