483
Novum Medical Products of NY, LLCNovum Medical Products of NY, LLC – FDA 483, Jul 13, 2021
Record Details
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.
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ID · f902bfe3-c6f6-48d2-beae-58920311c836
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