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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.