FDA 483 - Novum Medical Products of NY, LLC - July 13, 2021

Novum Medical Products of NY, LLC, a medical device manufacturer in Amherst, NY, was inspected by the FDA from July 9-13, 2021. The inspection revealed deficiencies in the firm's quality system, specifically concerning the establishment and implementation of corrective and preventive action procedures and document control procedures. These issues indicate a need for improved adherence to quality system regulations for medical device manufacturing.