FDA EIR - KBI Biopharma, Inc. - August 29, 2012

An abbreviated surveillance inspection of Kbi Biopharma, Incorporated, located in Durham, NC, was conducted by the FDA on August 28-29, 2012. This inspection, carried out under the regulatory framework of CP7356.002 Drug Process Inspections, specifically focused on the company's Quality and Laboratory Systems. Ms. Kathy S. Lee, Vice President of Quality and Regulatory, was the primary company representative. The inspection noted that Kbi Biopharma offers services including cell line development, process development, analytical method development, API manufacturing, and stability studies, although they had not conducted contract testing services for any client since their previous inspection in 2009. The company maintained its registration to attract new clients and support existing ones. Upon review of the firm's quality manual, which detailed training, deviation management, lab controls, audits, change control, and batch release, no objections were identified. Similarly, the review of laboratory control documentation, including SOPs for data review, result reporting, and investigations, found no issues. Crucially, at the conclusion of the inspection, no objectionable conditions were observed in Kbi Biopharma's procedures or practices. Consequently, no FDA Form 483, "Inspectional Observations," was issued, indicating compliance and no required actions for the company at that time. The inspection was classified as NAI (No Action Indicated), consistent with the previous inspection in 2009.