Wuxi Medical Instrument Factory in China Receives FDA Warning Letter
May 24th, 2025 // 3:00 pm @ jmpickett
Wuxi Medical Instrument Factory of the Jiangsu province in China received an FDA warning letter on April 4, 2025, for cGMP violations the agency observed in a November 2024 inspection at the manufacturing faciity in Wuxi. The warning letter states that drugs were packed, prepared, or held in unsanitary conditions. This risked contamination with health hazards and filth. Wuxi Medical responded to the FDA in December 2024, but this response was inadequate.
The FDA warning letter notes many unsanitary problems leading to adulterated drug products, including many dead insects in tubing, which are used to transfer the API from storage to drums. There were many pieces of unknown debris in processes for drugs that were labelled sterile.
FDA also found that since an earlier cGMP inspection, the firm had stopped its sterilization procedures without using a new procedure. FDA noted that the company doesn’t have a procedure for doing environmental monitoring for manufacturing observations. It did not ensure operators wore gowns, per the regualtions, which compromised the sterility of a drug product, whose name was redacted.
Wuxi Medical Instrument factor issued a voluntary recall of sterile drugs because of no sterility assurance and cGMP violations in February 2025, based on an agency recommendation. FDA put an import hold on the firm’s products in January.
