APHROZONE USA, INC. – FDA Inspection, Sep 17, 2018

Record Details

This FDA Inspection record concerns APHROZONE USA, INC., with an inspection on September 17, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: APHROZONE USA, INC.
Inspection Date: September 17, 2018
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Liming Zhang (FDA Associated Person)

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ID · 79fb4df7-33df-42cb-a9f7-0503bedfb1c8

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1065832
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.150Written distribution procedure

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FDA Inspection

APHROZONE USA, INC.September 17, 2018