FDA 483 - Pedia Parents Inc. DBA Pedia Pals - April 24, 2025

An FDA inspection of Pedia Parents Inc. DBA Pedia Pals, a medical device specification developer in Buffalo, NY, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, management reviews, and design reviews. These issues indicate a lack of robust quality system controls for medical device development.