Purepoint Inc. – FDA Inspection, Sep 27, 2010

Record Details

This FDA Inspection record concerns Purepoint Inc., with an inspection on September 27, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Purepoint Inc.
Inspection Date: September 27, 2010
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · ec54d18c-5253-4283-8547-b6c5b1186470

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 682631
FDA center: Human Drugs
Project area: Drug Quality Assurance

FDA Citations

21 CFR 211.68(a)Calibration/Inspection/Checking not done
21 CFR 211.165(a)Testing and release for distribution

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FDA Inspection

Purepoint Inc.September 27, 2010