FDA 483 - Cis Bio International - December 16, 2022

Cis Bio International, a drug manufacturing facility in Saclay, France, was inspected by the FDA. The inspection revealed significant deficiencies across multiple quality system areas, including failures to reject contaminated drug products, inadequate process validation, insufficient annual product reviews, and unvalidated test methods. These issues indicate a lack of robust controls to ensure the identity, strength, purity, and quality of drug products.