FDA 483 - Bio-Thesiometer USA - January 19, 2018

Bio-Thesiometer USA, a medical device manufacturer in Cleveland, OH, was cited for significant deficiencies in its quality system during an FDA inspection. The firm lacked established procedures for receiving, reviewing, and evaluating customer complaints, with the complaint form missing critical documentation. Additionally, the company had not developed written procedures for evaluating and submitting Medical Device Reports (MDRs).