FDA 483 - Bryan Medical Inc - July 23, 2021

Bryan Medical Inc, a medical device manufacturer in Cincinnati, OH, was cited for three observations during an FDA inspection. The firm failed to adequately establish procedures for design transfer and design validation for its Aeris Catheters, leading to issues with product distribution and testing. Additionally, the firm's complaint management procedures were found to be inadequate, with an uninvestigated complaint and unclear handling of complaints for foreign-manufactured products.