FDA 483 - Cogent Technology, Ltd. - February 14, 2019

An FDA inspection of Corinant Technology, Ltd., a medical device manufacturer in Woodbridge, Suffolk, United Kingdom, revealed significant deficiencies in their quality system. The firm failed to adequately validate several critical manufacturing processes for their Calcivis Imaging Device, including Surface Mount Technology, Automated Optical Inspection, gluing, and hand soldering. Additionally, the inspection found that the firm's sampling plans for incoming raw material inspection lacked valid statistical rationale, relying on fixed sample sizes of one unit regardless of lot size.