FDA Inspection
The Estee Lauder Inc.The Estee Lauder Inc. – FDA Inspection, Aug 6, 2015
Record Details
This FDA Inspection record concerns The Estee Lauder Inc., with an inspection on August 6, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- The Estee Lauder Inc.
- Inspection Date
- August 6, 2015
- Product Type
- Drugs
View Company Profile
ID · 0e33a234-a395-4a57-8dd1-3f5cfd8ea402
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 938546
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.28(b)Habits of good sanitation & health
- 21 CFR 211.180(c)Records not made readily available to FDA
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(4)Testing in same container - closure system
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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 | |
| January 26, 2018 | 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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