FDA EIR - KBI Biopharma, Inc. - December 03, 2021

KBI Biopharma, Inc., located in Boulder, CO, underwent a comprehensive FDA surveillance inspection from November 30 to December 3, 2021. The inspection was conducted under regulatory frameworks for Active Pharmaceutical Ingredient (API) process inspections and surveillance of protein drug substance manufacturers, referencing Current Good Manufacturing Practice (cGMP) guidance like ICH Q7. The company manufactures a commercial biologically derived API and acts as a contract testing laboratory.

The FDA issued a Form 483 highlighting two main observations. First, investigations into unexplained discrepancies, such as microbial contamination and elevated Total Organic Carbon (TOC) levels in the water system, were deemed incomplete, failing to consistently identify root causes. Second, deficiencies in equipment maintenance were noted, including the absence of established sanitization schedules or procedures for a water purification system in operation since 2004, and uncalibrated pressure gauges monitoring water manufacturing processes. An additional discussion item concerned damaged walls and cracks in the production facility, posing a potential contamination risk.

KBI Biopharma management agreed to implement necessary corrections and submit a written response to the FDA within 15 business days, outlining their proposed actions and timelines. The FDA informed the company of potential legal sanctions, such as seizure or injunctions, if serious conditions are not voluntarily corrected. KBI is also implementing a global deviation certification program to improve personnel training for investigations.