FDA 483 - Sigma-Aldrich Manufacturing LLC - January 31, 2020

This FDA Form 483 issued to Sigma-Aldrich Manufacturing LLC in Saint Louis, MO, details significant deficiencies in manufacturing process control, quality systems, and data integrity for drug substance production. Observations include repeated equipment failures with inadequate investigations, environmental monitoring shortcomings, and a lack of validated cleaning, equipment, and data acquisition systems. The findings indicate a need for comprehensive improvements in quality assurance and control.