Unimicro Medical Systems-Shenzhen Co., Ltd.

Warning LetterClosed

Roly Lee General Manager Unimicro Medical Systems-Shenzhen Co., Ltd. 201, Bldg 38 101 Heshui Kou Gongmingzhen Longgang Shenzhen 518106 ChinaFEI 3010806467Issued Jan 6, 2022Center for Devices and Radiological Health

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3010806467.

Violations10

Issue DateJan 6, 2022

Product TypeMedical Devices

StatusClosed

Closeout LetterMay 31, 2023

Letter Details

Firm: Unimicro Medical Systems-Shenzhen Co., Ltd.
Location: Roly Lee General Manager Unimicro Medical Systems-Shenzhen Co., Ltd. 201, Bldg 38 101 Heshui Kou Gongmingzhen Longgang Shenzhen 518106 China
FEI Number: 3010806467
Country: China
Issue Date: January 06, 2022
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Closed
Closeout Letter: May 31, 2023

Summary

Unimicro Medical Systems-Shenzhen Co., Ltd. manufactured Veress Pneumoperitoneum Needles in violation of FDA's Quality System Regulation (21 CFR Part 820), with the primary deficiency being failure to establish and maintain adequate procedures for controlling nonconforming products. During an FDA inspection in September 2021, investigators found that the company could not account for the disposition of multiple packages of heat-sealed nonconforming products, which were marked for "return to warehouse" with no documented final disposition, leaving the location and handling of these devices unknown. This adulteration finding indicated the company's manufacturing methods, facilities, and controls did not meet current good manufacturing practice requirements.

Unimicro Medical Systems-Shenzhen Co., Ltd. FDA Warning Letter, January 6, 2022