FDA 483 - iCRco, Inc. - July 01, 2022

iCRco, Inc., a Class II medical device manufacturer in Goleta, CA, was cited with two observations during an FDA inspection. The inspection revealed deficiencies in the firm's medical device reporting (MDR) procedures, specifically regarding the timely transmission and completeness of reports. Additionally, the firm failed to adequately examine labeling for accuracy, including the establishment of Unique Device Identifiers for its ICR 3600 Image Scanners.