FDA 483 - Sports Art America, Inc. - February 10, 2022

An FDA inspection of Sports Art America, Inc. in Mukilteo, WA, a medical device manufacturer, from February 7-10, 2022, revealed significant deficiencies across multiple quality system areas. The firm lacked adequate procedures for complaint handling, corrective and preventive actions, quality audits, management review, servicing verification, and document control. Several observations, including complaint handling and document control, were repeat findings, indicating a persistent lack of compliance with regulatory requirements.