BYD Precision Manufacture Co., Ltd

Warning LetterOpen

Liu Xiaoling General Manager BYD Precision Manufacture Co., Ltd Baolong Industrial, No. 3001 Baohe Road; Longgangjiedao Longgang Qu Shenzhen Shi Guangdong Sheng , 518116 ChinaFEI 3009545790Issued Sep 5, 2023Center 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 3009545790.

Violations12

Issue DateSep 5, 2023

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: BYD Precision Manufacture Co., Ltd
Location: Liu Xiaoling General Manager BYD Precision Manufacture Co., Ltd Baolong Industrial, No. 3001 Baohe Road; Longgangjiedao Longgang Qu Shenzhen Shi Guangdong Sheng , 518116 China
FEI Number: 3009545790
Country: China
Issue Date: September 05, 2023
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

BYD Precision Manufacture Co., Ltd manufactured surgical masks and N95 respirators that the FDA found to be adulterated due to failure to comply with current good manufacturing practice (CGMP) requirements under 21 CFR Part 820. The primary violation involved the company's failure to establish and maintain design control procedures, with no documented evidence of design input, output, review, verification, validation, transfer, changes, or design history files for their N95 respirator products. The inspection was conducted in May 2023 at the company's facility in Shenzhen, China, and the warning letter was issued in September 2023 following an inadequate response to the FDA's initial inspection observations.

BYD Precision Manufacture Co., Ltd FDA Warning Letter, September 5, 2023