FDA 483 - Pedia Parents Inc. DBA Pedia Pals - July 14, 2022

An FDA inspection of Pedia Parents Inc. DBA Pedia Pals in Buffalo, NY, a medical device specification developer, revealed seven significant observations. The firm lacked adequately established procedures across multiple critical quality system areas, including supplier control, corrective and preventive actions, nonconforming product control, design transfer and review, medical device reporting, and document control. These deficiencies indicate a need for comprehensive improvements to their quality management system.