Minaris Regenerative Medicine, LLC – FDA EIR, Apr 26, 2017

An FDA inspection of PCT, LLC, A Caladrius Company, was conducted from April 20-26, 2017, focusing on its human cells, tissues, and cellular and tissue-based products (HCT/Ps) operations, specifically concerning autologous cord blood stem cells. Operating under the HCT/Ps regulatory framework (CP 7341.002), this initial inspection revealed significant deficiencies in the firm's sterility testing proficiency. In both 2014 and 2015, PCT's internal sterility proficiency tests failed to meet the 80% acceptance criteria, showing 70% and 60% accuracy, respectively, and lacked adequate investigation into the root causes. These deficiencies remained unaddressed for extended periods, and minor labeling inconsistencies were also noted.

Initially, management stated these issues only affected undistributed cord blood units. However, post-inspection, PCT revealed the problematic sterility test was also applied to distributed NeoStem adult stem cells and other products manufactured between 2007-2010 for another client. The firm acknowledged the method lacked proper qualification for some products prior to 2014.

Required actions include PCT addressing the sterility testing failures, correcting labeling inconsistencies, and proactively informing affected physicians and clients about the compromised test results for distributed products. PCT also initiated Biological Product Deviation Reports (BPDRs) and a suitability testing study, committing to provide FDA with updates on their progress.