Hong Kong Zihua Pharmaceutical Ltd. – FDA Inspection, Sep 15, 2017

Record Details

This FDA Inspection record concerns Hong Kong Zihua Pharmaceutical Ltd., with an inspection on September 15, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Hong Kong Zihua Pharmaceutical Ltd.
Inspection Date: September 15, 2017
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Alice S. Tsao (FDA Associated Person)

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ID · f9d0702f-919e-4506-b722-8158284a1718

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1025270
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.166(b)Adequate number of batches on stability
21 CFR 211.160(b)Scientifically sound laboratory controls
21 CFR 211.68(a)Calibration/Inspection/Checking not done
21 CFR 211.180(e)(2)Items to cover on annual reviews
21 CFR 211.67(b)Written procedures not established/followed
21 CFR 211.80(a)Written Procedures Not Followed

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FDA Inspection

Hong Kong Zihua Pharmaceutical Ltd.September 15, 2017