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FDA Inspection
•Cosmetic Enterprises Ltd•September 26, 2025

Cosmetic Enterprises Ltd – FDA Inspection, Sep 26, 2025

Record Details

This FDA Inspection record concerns Cosmetic Enterprises Ltd, with an inspection on September 26, 2025, issued by the Los Angeles District Office, covering human drugs.

Company
Cosmetic Enterprises Ltd
Inspection Date
September 26, 2025
Product Type
Human Drugs
Office
Los Angeles District Office
Person
  • Gloria E. Andia (Issuing Officer)
View Company Profile

ID · 59b4407b-caf9-4c83-a2a6-1b72fc6b1dcd

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1284440
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued, view the record

FDA Citations

10
  1. 21 CFR 211.68(b)Computer control of master formula records
  2. 21 CFR 211.170(b)Reserve samples identified, representative, stored
  3. 21 CFR 211.192Extent of discrepancy, failure investigations
  4. 21 CFR 211.160(b)Scientifically sound laboratory controls
  5. 21 CFR 211.100(a)Absence of Written Procedures
  6. 21 CFR 211.63Equipment Design, Size and Location
  7. 21 CFR 211.84(d)(1)Identity Testing of Each Component
  8. 21 CFR 211.22(d)Procedures not in writing, fully followed
  9. 21 CFR 211.89Quarantine of Rejected Components et. al.
  10. 21 CFR 211.166(a)Results not used for expiration dates, storage cond.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Cosmetic Enterprises Ltd

5
DateClassificationOfficeProject area
June 11, 2021VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
August 16, 2016NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
March 5, 2012NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
May 9, 2011NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
October 8, 2008NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Cosmetic Enterprises Ltd
  • FDA Inspection 1144753 - 2021-06-11
  • 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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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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