Hong Qiangxing Shenzhen Electronics Limited

Warning LetterOpen

Zhu Shi Hong Vice President and Management Representative Hong Qiangxing Shenzhen Electronics Limited 2F, Yongcheng Boulevard Xicheng Industrial Area, Xixiang Road Bao'an Qu Shenzhen Shi Guangdong Sheng , 518126FEI 3010402752Issued Oct 28, 2025Center 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 3010402752.

Violations9

Issue DateOct 28, 2025

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Hong Qiangxing Shenzhen Electronics Limited
Location: Zhu Shi Hong Vice President and Management Representative Hong Qiangxing Shenzhen Electronics Limited 2F, Yongcheng Boulevard Xicheng Industrial Area, Xixiang Road Bao'an Qu Shenzhen Shi Guangdong Sheng , 518126
FEI Number: 3010402752
Country: China
Issue Date: October 28, 2025
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

Hong Qiangxing Shenzhen Electronics Limited, a Chinese manufacturer of wrist blood pressure monitors and transcutaneous electric nerve stimulator (TENS) devices, was found to be manufacturing adulterated medical devices in violation of Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 820. During an FDA inspection conducted August 4-7, 2025, investigators identified failures to establish and maintain procedures controlling device design to ensure specified design requirements were met, among other Quality System Regulation violations. The company's responses to the FDA 483 observations dated August 21, September 26, and October 8, 2025, were determined to be insufficient to address the noted compliance failures.

Hong Qiangxing Shenzhen Electronics Limited FDA Warning Letter, October 28, 2025