CELL CULTURE COMPANY LLC – FDA Inspection, Nov 17, 2017

Record Details

This FDA Inspection record concerns CELL CULTURE COMPANY LLC, with an inspection on November 17, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: CELL CULTURE COMPANY LLC
Inspection Date: November 17, 2017
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Scott A. Golladay

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ID · 7ddb1654-df67-441c-a8d1-ec0687e6fe6b

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1035839
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 211.68(a)Calibration/Inspection/Checking not done
21 CFR 211.22(d)Procedures not in writing, fully followed

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FDA Inspection

CELL CULTURE COMPANY LLCNovember 17, 2017