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FDA Inspection
•Clean Cosmetics, LLC•August 19, 2022

Clean Cosmetics, LLC – FDA Inspection, Aug 19, 2022

Record Details

This FDA Inspection record concerns Clean Cosmetics, LLC, with an inspection on August 19, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Clean Cosmetics, LLC
Inspection Date
August 19, 2022
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · a9774a49-1621-4ac0-8304-93ca839e5392

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
1178068
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

7
  1. 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
  2. 21 CFR 211.180(c)Records not made readily available to FDA
  3. 21 CFR 211.165(a)Testing and release for distribution
  4. 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
  5. 21 CFR 211.22(a)Lack of quality control unit
  6. 21 CFR 211.166(a)Lack of written stability program
  7. 21 CFR 211.22(d)Procedures not in writing, fully followed

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