FDA 483 - Rentschler Biopharma Inc. - March 22, 2023

Rentchler Biopharma Inc. in Milford, MA, a drug substance manufacturer, was cited for significant deficiencies across multiple areas during an FDA inspection. Observations included inadequate microbial contamination prevention, poor data integrity practices, widespread procedural deficiencies, untimely deviation management, and inadequate computerized system access controls. These issues indicate a systemic lack of control over critical manufacturing and quality processes.