483
Novum Medical Products of NY, LLCNovum Medical Products of NY, LLC – FDA 483, Dec 5, 2023
Record Details
Novum Medical Products of NY, LLC, a medical device manufacturer in Amherst, NY, received a Form FDA 483 with one repeat observation. The inspection revealed inadequacies in the firm's corrective and preventive action (CAPA) procedures, specifically concerning the verification of effectiveness and comprehensive issue resolution. This indicates a persistent issue with their quality system.
View Company Profile
ID · f2f93b93-43fc-4baa-9682-4e6f3d2efbcc
Violation Codes1
21 U.S.C. 374(b)
Full citation text and observation details available on the Dashboard.
Other documents for Novum Medical Products of NY, LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.