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FDA Inspection
•COSMAX, INC.•July 4, 2014

COSMAX, INC. – FDA Inspection, Jul 4, 2014

Record Details

This FDA Inspection record concerns COSMAX, INC., with an inspection on July 4, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
COSMAX, INC.
Inspection Date
July 4, 2014
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 55288820-4742-4243-853c-86ab14b937bf

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
888701
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

5
  1. 21 CFR 211.198(a)Adverse Drug Experience
  2. 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
  3. 21 CFR 211.65(a)Equipment construction - reactive surfaces
  4. 21 CFR 211.166(a)(1)Sample size - test intervals
  5. 21 CFR 211.111Establishment of time limitations

Full citation text and observation details available on the Dashboard.

Other FDA inspections of COSMAX, INC.

3
DateClassificationOfficeProject area
October 18, 2024VAIOffice of Inspections and InvestigationsDrug Quality Assurance
October 31, 2018VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 19, 2017VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for COSMAX, INC.
  • FDA Inspection 1251979 - 2024-10-18
  • FDA Inspection 1071488 - 2018-10-31
  • FDA Inspection 999717 - 2017-01-19

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