FDA 483 - Catalent Belgium SA - November 25, 2016

An FDA inspection of Patheon Belgium SA, a contract manufacturer in Brussels, revealed significant deficiencies in preventing microbiological contamination of sterile drug products. Observations included an unapproved intervention in an aseptic filling area without Quality Assurance concurrence and inadequate disinfectant efficacy studies for clean rooms and equipment. These issues indicate a high risk to product sterility and quality.