FDA 483 - Ferring Production Inc. - March 07, 2025

Ferring Production Inc. in Parsippany, New Jersey, a finished product manufacturer, was cited for significant quality control deficiencies during an FDA inspection. Observations included failures in thoroughly investigating out-of-specification results and leaks, inadequate contamination prevention measures in aseptic processing areas, and insufficient sterility testing for ADSTILADRIN. Additionally, the firm lacked proper written procedures for production and process controls, specifically regarding shipping integrity.