MacroGenics, Inc – FDA 483, Apr 6, 2021

MacroGenics, Inc. in Rockville, MD, a drug substance manufacturer, was cited for multiple significant deficiencies during an FDA inspection. Observations included inadequate procedures for preventing microbiological contamination, insufficient controls for electronic data systems, and failures in cleaning validation, environmental control, and utility qualification. These issues indicate a lack of robust quality systems impacting product quality and data integrity.