Singaporean company barred from selling devices in U.S. after turning down FDA inspection

A subsidiary of Singapore's Biosensors International can no longer sell devices in the U.S. because it failed to respond to a request for FDA inspection. Biosensors spokesman John Wong told Regulatory Focus that the company received the notification of FDA inspection on Dec. 21, 2015, or "over the holiday time. As we did not respond to FDA within the 5-day window as required by the FDA due to the holidays, we missed the required deadline. We have since responded affirmatively to FDA, which we welcome them to inspect. We are waiting for their response and are ready to provide further clarifications and support." This is the fifth instance of a company in Asia turning down an inspection request (whether intentionally or not). More from FiercePharmaAsia

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