483
Novitium Pharma LLCFDA 483 - Novitium Pharma LLC - February 04, 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.
Record Details
An FDA inspection of Novitium Pharma, Inc. in East Windsor, New Jersey, revealed significant deficiencies in their quality system and laboratory controls. Observations included inadequate assessment and control of changes to approved drug applications, as well as incomplete records for laboratory reference standards. These findings indicate systemic issues with the firm's quality unit procedures and documentation practices.
Open in Dashboard
ID · 0aefdaf2-ddff-41b3-ae7b-8d54b3c4dc1d