FDA 483 - Kedrion Biopharma Inc. - June 25, 2021

An FDA inspection of Medisca Biopharma Inc. in Melville, NY, an API and Intermediate Manufacturer, revealed significant deficiencies in facility cleanliness and process control. Inspectors observed powdery substances and dried matter on equipment labeled as "clean," indicating inadequate cleaning practices. Furthermore, there was no current assessment of the cleaning process, including microbial control, which could impact product quality.