Emergent BioSolutions Canada Inc. – FDA 483, May 10, 2022

During an inspection from May 2 to May 10, 2022, Emergent BioSolutions Canada Inc., a licensed biological drug manufacturer, received an FDA Form 483 outlining significant observations. The inspection, conducted under the Federal Food, Drug, and Cosmetic Act, identified several critical issues impacting the sterility and quality of their drug products.

Main violations included inadequate procedures to prevent microbial contamination of sterile products, with specific deficiencies observed in operator gowning within critical aseptic processing areas. The fully automated Vanrx system filling isolator also had multiple shortcomings: insufficient cleaning procedures, sterilization validation that did not adequately challenge all critical components, and a lack of viable environmental monitoring during aseptic filling operations. Additionally, laboratory procedures for controlling microbiological samples were found to be insufficient, as evidenced by the presence of outdated sample plates.

These observations indicate a need for the company to implement comprehensive corrective actions to address these deficiencies, enhance microbial control, and ensure compliance with regulatory standards for manufacturing sterile drug products.