Loading…
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.