FDA 483 - Avista Pharma Solutions, Inc. dba Cambrex - July 25, 2025
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.
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.
ID · dda545e9-7e67-4c8e-a7de-c638725bd84e