Zhuhai Aofute Medical Technology Co., Ltd. – FDA Inspection, Jul 18, 2019

Record Details

This FDA Inspection record concerns Zhuhai Aofute Medical Technology Co., Ltd., with an inspection on July 18, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Zhuhai Aofute Medical Technology Co., Ltd.
Inspection Date: July 18, 2019
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Cheryl A. Clausen

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ID · 3faa7a26-ecc3-4ad8-be50-3f19a126ff81

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1098875
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued
Enforcement: Warning Letter

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FDA Inspection

Zhuhai Aofute Medical Technology Co., Ltd.July 18, 2019