FDA 483 - Curia Global, Inc. - May 09, 2025
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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