FDA EIR - KBI Biopharma, Inc. - October 09, 2009

KBI Biopharma, Inc. in Durham, NC, was subject to an FDA Preapproval Inspection from October 5-9, 2009. This inspection, conducted under compliance programs for Drug Manufacturing and Preapproval Inspections, focused on evaluating the company's control laboratory operations, quality system, good manufacturing practices (GMP), quality agreements, analytical methodologies, and equipment validation pertinent to a drug substance for a Biologics License Application. Significantly, the inspection concluded with no observed deviations in KBI Biopharma's procedures, practices, or data related to the BLA and Quality Agreement. As a result, no FDA-483 inspectional observations were issued, and the district recommended approval.

While no formal violations were found, the FDA investigator discussed several recommendations with management. Concerns were raised regarding the potential for calculation errors due to the use of unlocked Excel spreadsheets for analytical results, with a suggestion to validate and lock these spreadsheets. Management acknowledged this, indicating the client was in the process of creating and sharing validated spreadsheets. Recommendations also included applying a revised method of reporting individual test results across all clients, rather than averages, to better identify variability, and to maintain more specific document change history records. KBI's leadership was receptive to these suggestions.