FDA 483 - Dynofit Inc. - September 18, 2019

Dynafit Inc. in Carrollton, TX, a medical device manufacturer, received a Form 483 with three observations during an FDA inspection. The firm failed to adequately maintain device history records, did not document supplier evaluations, and used unvalidated electronic record systems lacking proper audit trails. These issues indicate significant deficiencies in the firm's quality management system and data integrity practices.