FDA 483 - PROXIMAGEN LLC - March 05, 2019
Discuss this record with AI
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.
An FDA inspection of Proximagen LLC in Plymouth, MN, revealed multiple deficiencies in the firm's quality system and manufacturing controls. The company failed to establish adequate design control procedures for its Nayzilam device, lacked proper monitoring for process parameters, and did not have procedures for identifying valid statistical techniques. Additionally, a management representative was not timely appointed, and quality agreements with contract manufacturers were not clearly defined regarding services.
ID · f647d077-fea4-4af2-b59e-a25e742fa28b