C3 Co Ltd. – FDA Inspection, Jul 12, 2019

Record Details

This FDA Inspection record concerns C3 Co Ltd., with an inspection on July 12, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: C3 Co Ltd.
Inspection Date: July 12, 2019
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Andrew K. Haack (FDA Associated Person)

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ID · efb31b4b-a073-4fb5-b5f0-36c9db8fcd20

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1095985
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
21 CFR 211.84(d)(2)Reports of Analysis (Components)
21 CFR 211.125(a)Strict control not exercised over labeling issued
21 CFR 211.165(a)Testing and release for distribution
21 CFR 211.188(b)(8)Labeling Control Records and Label Copies
21 CFR 211.100(a)Absence of Written Procedures
21 CFR 211.166(a)(3)Valid stability test methods
21 CFR 211.180(e)(2)Items to cover on annual reviews

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FDA Inspection

C3 Co Ltd.July 12, 2019