FDA 483 - MacroGenics, Inc - August 28, 2023

Macrogenics, Inc., a drug substance manufacturer in Rockville, MD, was cited with three observations during an FDA inspection. The observations highlight deficiencies in the firm's stability program, quality control unit procedures for HEPA filter certifications, and the thoroughness of investigations into unexplained discrepancies, including late stability testing and cleanroom air changes. These issues indicate a systemic failure to follow established procedures and adequately investigate deviations.