Xiantao Zhongtai Protective Products Co.,LtdAugust 1, 2019

FDA 483 - Xiantao Zhongtai Protective Products Co.,Ltd - August 01, 2019

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An FDA inspection of Xiantao Zhongtai Protective Products Co.,Ltd in Xiantao City, China, revealed four observations related to inadequate procedures. The firm was cited for deficiencies in preventing contamination, equipment maintenance, storage area control, and quality audit practices. These issues indicate a need for improved procedural controls within the manufacturing and quality systems.

Company: Xiantao Zhongtai Protective Products Co.,Ltd
Inspection Date: August 1, 2019
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Dedicated Device Cadre
John A. Sciacchitano (investigator)

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ID · dbe1d749-c812-4510-926d-9f3b7944463d