FDA 483 - Modavar Pharmaceuticals - January 27, 2023

Modavar Pharmaceuticals, LLC, a non-sterile drug manufacturer in Frederick, MD, received an FDA Form 483 with eight observations following an inspection from January 18-27, 2023. The inspection revealed significant deficiencies in equipment qualification and maintenance, component testing, production controls, stability programs, and data integrity for computerized systems. These issues indicate a lack of adequate controls to ensure drug product quality and compliance with GMP regulations.