Issue Date: January 9, 2017
Chinese firm hampers FDA inspection
FDA has banned from the U.S. drugs made by Baoying County Fukang Medical Appliance after the company hampered the agency’s work. During an inspection in June, FDA officials observed that the company does not properly maintain the cleanliness of its finished product warehouse or provide sanitary facilities to its staff. And a company manager refused to explain how it conducts microbiological testing of products it ships to the U.S., claiming that the procedure is a trade secret. FDA did not disclose what Fukang makes. On websites where its products are sold, the company is described as a supplier of medical consumables such as cotton balls and tongue depressors.
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