FDA 483 - Avista Pharma Solutions, Inc. dba Cambrex - September 27, 2013

Microtest Laboratories, Inc. in Agawam, MA, was inspected by the FDA from September 16-27, 2013, and received eight observations. The inspection revealed significant deficiencies in quality control, aseptic processing, environmental monitoring, and validation of sterile drug product manufacturing. Key issues include releasing sterile injectable products without complete testing, inadequate smoke studies, and failures in investigating discrepancies and validating sterilization processes.