Charles River Laboratories Cell Solutions Inc – FDA EIR, Feb 19, 2010

An FDA inspection of Key Biologics LLC, located at 1256 Union Ave Ste 200 Memphis, TN, was conducted from February 17 to February 19, 2010. This inspection focused on the company's blood banking operations, which primarily involve collecting blood and blood products for research and diagnostic use. The facility is registered as an unlicensed blood bank and also collects allogeneic peripheral blood stem cells for research. The inspection was performed in accordance with FDA compliance program 7342.001, covering licensed and unlicensed blood banks, and adhered to relevant regulations outlined in 21 CFR Part 606, 21 CFR Part 610, and 21 CFR Part 640. During the inspection, FDA investigators observed various operations, including donor registrations, blood and apheresis collections, and preparation of blood components. They also thoroughly reviewed critical documents such as the company's Standard Operating Procedure Manual, laboratory quality control records, equipment logs, and numerous donor files. Importantly, the inspection concluded with "No Action Indicated," as no significant objectionable conditions were identified. Consequently, a Form FDA 483, which lists inspectional observations requiring corrective action, was not issued. No specific corrective actions were required from the company as a result of this inspection. A routine re-inspection was scheduled for January 2012.