FDA EIR - KBI Biopharma, Inc. - September 29, 2020

An FDA pre-license inspection was conducted at KBI Biopharma in Durham, NC, from September 23-29, 2020. This was the facility's first commercial Good Manufacturing Practice (GMP) inspection, focusing on Drug Substance manufacturing areas, quality control laboratories, and warehousing. The inspection was carried out under the regulatory guidance of CP 7356.002M, CP 7346.832, and ICH Q7, aligning with the Food, Drug and Cosmetics Act.

Inspectors identified several deficiencies, resulting in a 5-item Form FDA 483. Key observations included the quality unit's consistent failure to adhere to established procedures and written standard operating procedures. Significant issues were noted with computerized systems, lacking adequate controls to prevent unauthorized data access or changes, thus compromising data integrity. The quality unit also failed to ensure critical deviations and laboratory investigations were thoroughly investigated and resolved. Furthermore, deficiencies were found in ensuring personnel completed required training before performing activities. Verbal discussions also highlighted the absence of scientific justification for the pest control strategy.

KBI Biopharma management committed to providing a comprehensive response to the inspectional observations within 15 days, outlining their corrective actions.