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

Avista Pharma Solutions, Inc. in Agawam, MA, was inspected and cited for multiple deficiencies related to quality control, facility maintenance, and computer system controls. The inspection revealed failures to investigate environmental monitoring discrepancies, maintain clean and repaired facilities, adhere to quality unit procedures for environmental monitoring data approval, and implement adequate computer system access controls. These issues indicate significant concerns regarding the firm's adherence to cGMPs in its drug product sterility and endotoxin testing operations.