Kinetics Derma Beauty, LLC – FDA Inspection, May 3, 2024

Record Details

This FDA Inspection record concerns Kinetics Derma Beauty, LLC, with an inspection on May 3, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Kinetics Derma Beauty, LLC
Inspection Date: May 3, 2024
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Timothy H. Vo (Company Rep)

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ID · f7dced6a-739a-4db4-aed9-4caad694af3f

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1238640
FDA center: Human Drugs
Project area: Drug Quality Assurance

FDA Citations

21 CFR 211.165(d)Acceptance criteria for sampling & testing
21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
21 CFR 211.22(a)Authority lacking to review records, investigate errors
21 CFR 211.166(a)Lack of written stability program
21 CFR 211.22(d)Procedures not in writing, fully followed
21 CFR 211.111Establishment of time limitations
21 CFR 211.84(d)(2)Reports of Analysis (Components)

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FDA Inspection

Kinetics Derma Beauty, LLCMay 3, 2024