Charles River Laboratories Cell Solutions Inc – FDA EIR, Sep 3, 2009

This FDA inspection report details a comprehensive review of Key Biologics LLC, located at 1256 Union Ave Ste 200, Memphis, TN. The inspection, conducted from September 2 to September 3, 2009, was an initial assessment of the firm, which had been operating for three months at the time. The inspection focused on the company's handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), specifically Hematopoietic stem/progenitor cells derived from peripheral blood, used for research purposes. Key Biologics LLC also engages in donor phlebotomy for Platelet and Source Leukocyte collection, and pre-screening of first-time donors. The review encompassed Communicable Disease Testing, adherence to Good Tissue Practices (GTPs), and an examination of written procedures. No objectionable conditions or violations were observed during the inspection, and consequently, an FDA Form 483 was not issued. The facility received a "No Action Indicated" (NAI) classification, indicating full compliance with regulatory requirements at the time of the inspection. No samples were collected, and no refusals were encountered. As a result, no specific corrective actions were required from the company. A routine follow-up inspection was scheduled for September 2010 to ensure continued adherence to established standards.