Holymed Products Co., Ltd.June 19, 2019

FDA 483 - Holymed Products Co., Ltd. - June 19, 2019

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Record Details

Holymed Products Co. Ltd., a medical device contract manufacturer in Changzhou, China, was cited with two observations during an FDA inspection. The firm failed to adequately control environmental conditions and maintain related records for device manufacturing. Additionally, the company did not maintain complete Device History Records for certain products.

Company: Holymed Products Co., Ltd.
Inspection Date: June 19, 2019
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Shaquenta Perkins

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ID · 20a8ea68-17ad-4e4e-959a-956a5e5c5ba6