FDA Inspection
Estee Lauder Cosmetics Ltd.Estee Lauder Cosmetics Ltd. – FDA Inspection, Sep 19, 2014
Record Details
This FDA Inspection record concerns Estee Lauder Cosmetics Ltd., with an inspection on September 19, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Estee Lauder Cosmetics Ltd.
- Inspection Date
- September 19, 2014
- Product Type
- Drugs
View Company Profile
ID · 3b33776b-4ec6-46f2-81cf-eb84230a358e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 897811
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
Showing 10 of 14 citations.
Full citation text and observation details available on the Dashboard.
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 29, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 26, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Estee Lauder Cosmetics Ltd.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.