Wang Jun
General Manager
Qianjiang Kingphar Medical Material Co Ltd.
Yuanguang Road
Qianjiang Shi
Hubei Sheng , 433100
China
Daniel@qjmdmgauze.comFEI 3002897187Issued Oct 3, 2025Center for Devices and Radiological Health
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 3002897187.
Violations2
Issue DateOct 3, 2025
Product TypeMedical Devices
StatusOpen
Letter Details
Firm
Qianjiang Kingphar Medical Material Co Ltd.
Location
Wang Jun
General Manager
Qianjiang Kingphar Medical Material Co Ltd.
Yuanguang Road
Qianjiang Shi
Hubei Sheng , 433100
China
Daniel@qjmdmgauze.com
FEI Number
3002897187
Country
China
Issue Date
October 03, 2025
Issuing Office
Center for Devices and Radiological Health
Product Type
Medical Devices
Status
Open
Summary
Qianjiang Kingphar Medical Material Co Ltd., a Chinese manufacturer of surgical masks, wound dressings, sterilization wraps, and surgical drapes, was found to be in violation of Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 820. The company failed to establish and maintain adequate cleaning and inspection procedures for equipment and surfaces in its Packaging Clean Room, creating risk of product contamination that could adversely affect quality. An FDA inspection conducted June 30–July 3, 2025, identified these adulteration issues, which the company's July 21, 2025 response failed to adequately address.
Qianjiang Kingphar Medical Material Co Ltd. FDA Warning Letter, October 3, 2025
Talk to a Specialist