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# Quality System Violations at Hong Qiangxing Electronics
- URL: https://www.fdaweb.com/quality-system-violations-at-hong-qiangxing-electronics/
- Published: 2025-11-25T12:00:00.000Z
- Updated: 2026-09-14T15:27:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160279

An 8/4-8/7 FDA inspection at Hong Qiangxing Shenzhen Electronics in Shenzhen, Guangdong, China, found Quality System Regulation violations in the firm’s manufacturing of wrist blood pressure monitors, transcutaneous electric nerve stimulators, and powered muscle stimulator devices. A just-released 10/28 [Warning Letter](ttps://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hong-qiangxing-shenzhen-electronics-limited-718112-10282025) says the specific violations were:

- failure to establish and maintain procedures to control the design of the devices to ensure that specified design requirements are met;
- failure to adequately establish procedures to control product that does not conform to specified requirements;
- failure to adequately establish procedures for corrective and preventive action;
- failure to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit; and
- failure to adequately establish procedures for identifying product during all stages of receipt, production, distribution, and installation.

FDA says the firm’s responses to the first three inspection observations were inadequate, while its responses to the last two observations appeared to be adequate.

Hong was told to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, with documentation of the actions, and a schedule for completing the corrections.