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483
•Holymed Products Co., Ltd.•June 19, 2019

Holymed Products Co., Ltd. – FDA 483, Jun 19, 2019

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
View Company Profile

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

Other documents for Holymed Products Co., Ltd.
  • EIR - 2019-06-19June 19, 2019

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