FDA WARNING_LETTER - Hubei Qianjiang Kingphar Medical Material Co. Ltd. - July 03, 2025

Qianjiang Kingphar Medical Material Co Ltd. received an FDA Warning Letter (CMS #716715) on October 3, 2025, following an inspection from June 30 to July 3, 2025. The FDA determined that the company"s medical devices, including surgical masks and wound dressings, were adulterated under the Federal Food, Drug, and Cosmetic Act, as their manufacturing practices did not conform to the Quality System regulation (21 CFR Part 820).

Main violations included the failure to establish and maintain adequate procedures to prevent contamination (21 CFR 820.70(e)). Inspectors observed structural deficiencies and widespread dirt and filth in ISO 8 cleanrooms, contradicting company records. This was a repeat observation from a 2013 inspection, and the company’s corrective action plan was deemed inadequate.

Additionally, the company failed to establish and maintain procedures for controlling environmental conditions (21 CFR 820.70(c)). There were no established alert or warning limits for particle counts in cleanrooms, and procedures for handling excursions were unclear. The FDA"s assessment of the company"s response on this issue is currently undetermined.

Qianjiang Kingphar Medical Material Co Ltd. must respond in writing within fifteen business days. The response must detail specific corrective actions, a plan to prevent future violations, supporting documentation, and a timetable for implementation if corrections extend beyond the specified period. English translations are required for all non-English documents.