FDA 483 - InfuTronix LLC - August 16, 2023

InfuTronix LLC, a medical device manufacturer in Natick, MA, received a Form 483 with four repeat observations highlighting significant quality system deficiencies. The firm failed to adequately establish corrective and preventive action procedures, investigate device complaints in a timely manner, and submit Medical Device Reports within the required 30 days. Additionally, management did not conduct regular reviews of the quality system.