FDA 483 - Avista Pharma Solutions, Inc. dba Cambrex - July 25, 2025

Avista Pharma Solutions, Inc. in Agawam, MA, was inspected and cited for significant deficiencies in its control laboratory operations. Observations included failures to investigate environmental monitoring discrepancies, maintain clean and repaired facilities, adhere to quality unit procedures for data review, and implement adequate computer system controls for data integrity. These issues indicate a lack of robust quality systems and facility maintenance for drug product sterility and endotoxin testing.