FDA 483 - Specialty Process Labs LLC - July 21, 2025

Specialty Process Labs, LLC. in Phoenix, AZ, an API drug manufacturer, was cited for significant quality control and manufacturing process deficiencies during an FDA inspection. Observations included releasing finished API product without complete testing, failing to validate manufacturing process stages and extended hold times for intermediates, and not reviewing audit trails for analytical testing data. These issues indicate a lack of robust quality systems and control over product release and manufacturing processes.