FDA EIR - KBI Biopharma, Inc. - April 11, 2018

An FDA inspection of KBI Biopharma, Inc. in Durham, NC, was conducted from April 9-11, 2018. This routine, abbreviated inspection focused on the contract, biotech API manufacturer and testing laboratory, operating under Compliance Program 7356.002M, which pertains to inspections of licensed biological therapeutic drug products, implicitly requiring adherence to current Good Manufacturing Practices. While no FDA Form 483 was issued, two verbal observations were noted. The first issue concerned excessively long deviation close times, with 683 deviations since the previous inspection exceeding the documented 30-day target. Management was aware of this and had already initiated a project charter to address the backlog. Future corrective actions include updating the Standard Operating Procedure to allow deviation closure without client approval and increasing staffing in Quality Assurance and Production. The second observation involved inadequate qualification of an ISO 5 filling area. The area lacked performance qualification beyond non-viable air particulate readings and did not have active differential pressure monitoring to prevent potential backflow from the surrounding ISO 7 room. Airflow qualification was only conducted under static, "at rest" conditions. In response, KBI Biopharma initiated a Corrective and Preventive Action (CAPA) to perform smoke studies during active operations and establish a requirement for periodic smoke studies to confirm the area meets ISO 5 conditions.