On Dec. 8, the U.S. Food and Drug Administration issued a warning letter addressed to Yikai Fu, the general manager of the China-based medical supply manufacturer Baoying County Fukang Medical Appliance, citing six violations identified during a June inspection the company has yet to resolve. The FDA released the letter on Tuesday.
According to the company's website, Baoying manufactures medical cotton balls, medical silver, medical cotton buds, medical gauze and bandages among other products.
During the agency's inspection, the FDA investigator detected large quantities of unknown black mold on the floors and walls of one of the company's warehouses. Additionally, standing water and live insects were found at the entrance of the same warehouse.
Tthe FDA investigator also found no adequate washing facility for employees at the site and only one on-site bathroom with visible sewage and no running water.
According to the letter, when prompted to disclose the microbiological testing processes for products distributed in the U.S. during the FDA's inspection, the Baoying representative said the information was a protected trade secret.
In the letter, the FDA said, "Until you correct all violations completely and we confirm your compliance with [Current Good Manufacturing Practice regulations], FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer."
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