FDA 483 - F & A Foundation - May 09, 2025

F & A Foundation, a class II medical device manufacturer in Tulsa, OK, was cited for multiple quality system deficiencies during an FDA inspection. The firm lacked adequate procedures for design validation, design change control, and managing nonconforming products. Additionally, issues were noted with supplier control and the submission of required information to the Global Unique Device Identification Database (GUDID).