FDA 483 - APS Materials, Inc. - January 30, 2020

APS Materials, Inc., a medical device manufacturer in Dayton, OH, was inspected by the FDA from January 28-30, 2020. The inspection revealed deficiencies in the firm's complaint handling system, specifically regarding the maintenance of complaint files and the completeness of complaint investigation records. These issues indicate a lack of adequate procedures for evaluating Medical Device Reporting requirements and documenting essential investigation details.