FDA Issues Warning to Chinese Manufacturer Over Sterility Failures

In November 2024, the FDA identified major GMP violations at Wuxi Medical Instrument Factory Co., Ltd., including serious hygiene issues and false claims of product sterility. Products were labeled 'sterile' without sterilization or testing. Inspectors found unsanitary conditions—dead insects in tubing, contaminated containers, and soiled ceilings over open production areas. Hoses were damaged and leaking, and aseptic procedures were lacking. The company had stopped sterilization without validation, failed to conduct sterility tests, and didn’t monitor environmental hygiene.

Raw materials weren’t identity-tested, supplier qualifications were absent, and production water wasn’t tested. An inadequate stability program meant claimed expiry dates lacked supporting data.

On January 21, 2025, the FDA ordered a product recall, carried out on February 11. The agency deemed the company’s quality system wholly deficient, requiring major corrective action to meet GMP standards.

18-06-2025