FDA Inspection
Cosmetic Enterprises LtdCosmetic Enterprises Ltd – FDA Inspection, Jun 11, 2021
Record Details
This FDA Inspection record concerns Cosmetic Enterprises Ltd, with an inspection on June 11, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Cosmetic Enterprises Ltd
- Inspection Date
- June 11, 2021
- Product Type
- Drugs
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ID · f5dffd78-e7ec-46ee-b64d-60c098ab60a4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1144753
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(7)Signatures and dates--person who performs test
- 21 CFR 211.115(a)Reprocessing procedures not written or followed
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Cosmetic Enterprises Ltd
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2025 | VAI | Los Angeles District Office | Drug Quality Assurance |
| August 16, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 5, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 9, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 8, 2008 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Cosmetic Enterprises Ltd
- FDA Inspection 1284440 - 2025-09-26
- FDA Inspection 981328 - 2016-08-16
- FDA Inspection 773368 - 2012-03-05
- FDA Inspection 723725 - 2011-05-09
- FDA Inspection 542822 - 2008-10-08
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