ZhongHong (DongGuan) Abrasives Co. Ltd. – FDA Inspection, Jul 26, 2019

Record Details

This FDA Inspection record concerns ZhongHong (DongGuan) Abrasives Co. Ltd., with an inspection on July 26, 2019, issued by the Center for Devices and Radiological Health, covering devices.

Company: ZhongHong (DongGuan) Abrasives Co. Ltd.
Inspection Date: July 26, 2019
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: John A. Sciacchitano (Company Rep)

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ID · 3d70fd8d-41d9-4e3d-85c7-a089d460dc7f

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1098903
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.184DHR - not or inadequately maintained
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures

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FDA Inspection

ZhongHong (DongGuan) Abrasives Co. Ltd.July 26, 2019