FDA 483 - KBI Biopharma, Inc. - June 18, 2024

During an inspection conducted from June 11-14 and 17-18, 2024, KBI Biopharma, Inc. in Durham, North Carolina, received an FDA Form 483. The primary observation cited inadequate temperature qualifications for the firm's Good Manufacturing Practice (GMP) ambient storage areas. Specifically, the inspection noted that critical resins essential for manufacturing Drug Substance Intermediate (DSI) were stored in areas not qualified for long-term ambient temperature storage. Similarly, GMP materials, such as media plates used for DSI microbial testing, were found in unqualified ambient conditions within the Quality Control Microbiology lab. Furthermore, critical reagents and chemicals vital for DSI characterization, biophysical, and biochemical testing were also stored in ambient conditions in QC Analytical Laboratories that lacked proper temperature qualification. These observations highlight deficiencies in maintaining appropriate environmental controls for materials critical to product quality and safety, as per GMP standards. KBI Biopharma, Inc. is expected to respond to the FDA 483 with a comprehensive plan outlining corrective and preventive actions to address these identified storage control issues and ensure compliance with regulatory requirements.