Curia Global, Inc. – FDA 483, May 9, 2025
An FDA inspection of CURIA GLOBAL INC in Albany, NY, an API manufacturer, revealed significant deficiencies across multiple areas. Observations included inadequate facility maintenance with evidence of live mice activity, failure to demonstrate reproducible manufacturing processes for excipients, and lack of scientific-based stability data to support retest or expiry dates. Additionally, the firm failed to qualify critical equipment used in excipient manufacturing, indicating serious GMP non-compliance.
ID · 955787bf-f8bf-4e33-bc9c-54878e62cb07
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.