FDA 483 - Catalent Maryland, Inc. - November 04, 2019

An FDA inspection of Catalent Maryland, a drug manufacturer in Baltimore, revealed significant deficiencies in their sterile drug product manufacturing processes and quality control investigations. Observations included inadequate procedures to prevent microbiological contamination, uncertified cleanrooms, and a failure to conduct root cause assessments for unexplained discrepancies. These issues indicate a lack of adherence to good manufacturing practices.