FDA Inspection
The Estee Lauder Inc.The Estee Lauder Inc. – FDA Inspection, Jan 26, 2018
Record Details
This FDA Inspection record concerns The Estee Lauder Inc., with an inspection on January 26, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 193e8e13-328e-40a5-ba36-e8e68149e594
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1038726
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- FDCA 760(b)(1)Failure of responsible person to report AE (non-RX Drug)
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of The Estee Lauder Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 14, 2025 | Not classified | New York District Office | |
| August 6, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 5, 2013 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| May 25, 2012 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| May 25, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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