FDA EIR - KBI Biopharma, Inc. - January 13, 2022

An FDA Preapproval Inspection of KBI Biopharma, Inc. in Durham, NC, was conducted from January 10-13, 2022. This inspection, carried out under Compliance Program 7346.832 for Pre-Approval Inspections, focused on evaluating the contract drug manufacturer's readiness for commercial contract laboratory operations, conformance to specific application requirements, and overall data integrity for certain testing. The inspection covered Laboratory, Chemical/Physical Testing and Laboratory, Biological Testing profiles.

Notably, no Form FDA 483 Inspectional Observations were issued at the conclusion of this current inspection. The FDA investigator reviewed the firm’s previously submitted corrections to observations made during a September 2020 Prelicense Inspection, specifically those related to laboratory operations, and found them to be adequate. The firm appeared to have an established quality system, and no discrepancies were noted regarding analytical methods or data integrity during the audit of raw data. While no specific violations were identified during this visit, management was reminded of their ongoing responsibility for compliance with the U.S. Food Drug and Cosmetic Act.