FDA 483 - Huestis Machine Corporation - June 30, 2022

An FDA inspection of Huestis Machine Corporation, a medical device manufacturer in Bristol, RI, from June 15-30, 2022, revealed six significant deficiencies in its quality system. The observations included issues with product certification testing, design change procedures, corrective and preventive actions, complaint handling, medical device reporting, and software validation. Several of these findings were repeat observations, indicating persistent non-compliance with regulatory requirements.