FDA Inspection
Estee Lauder Cosmetics Ltd.Estee Lauder Cosmetics Ltd. – FDA Inspection, Sep 29, 2017
Record Details
This FDA Inspection record concerns Estee Lauder Cosmetics Ltd., with an inspection on September 29, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Kara D. Dobbin (Issuing Officer)
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ID · 574d94b1-8ad8-47da-8e4f-1b563fc82032
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1027659
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.188(b)(1)Dates not included for each significant step
- 21 CFR 211.101(b)Measured components for manufacturing
- 21 CFR 211.103Yield calculations not verified by 2nd person
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Other FDA inspections of Estee Lauder Cosmetics Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 24, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 19, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 26, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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