FDA 483 - Cook Incorporated - February 07, 2020

Cook, Inc., a medical device manufacturer in Bloomington, IN, was inspected by the FDA from January 27 to February 7, 2020. The inspection revealed significant deficiencies in their quality system, including inadequate corrective and preventive action procedures, insufficient process controls for temporary manufacturing deviations, and failures in complaint handling. These issues led to product recalls and, in one instance, a reported death associated with a delaminating Flexor sheath.