Charles River Laboratories Inc – FDA EIR, Jan 22, 2015

An FDA inspection of Cognate Bio Services Inc., a cellular therapy contract manufacturer in Memphis, TN, was conducted from January 20-22, 2015. This routine inspection was part of the FY'15 Work Plans and followed Compliance Program 7321.002 for Human Cells, Tissue, and Cellular and Tissue-Based Products (HCT/P). Cognate Bio Services operates as a contract manufacturer for clinical-based cellular therapy products, handling packaging, processing, storage, labeling, and distribution. Although the firm's registration included umbilical cord blood stem cells, it was verified that these were not being manufactured during the inspection. The review encompassed equipment quality control, the quality plan, and standard operating procedures. Crucially, the inspection concluded with no observed objectionable practices, and therefore, an FDA-483, Notice of Inspectional Observations, was not issued to management. No specific regulatory actions were required as no issues were identified; only the firm's operational status was to be updated for future re-inspections.