FDA EIR - Eurofins CellTx Inc - September 20, 2024

An FDA inspection of Eurofins CellTx Inc., a living tissue donor testing laboratory in Tucson, AZ, was conducted from September 11-20, 2024. This initial inspection, guided by Compliance Program 7341.002 for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), revealed significant deficiencies. Seven observations were cited on an FDA-483 form. Key violations included inaccurate records, specifically microbiology reports that misrepresented growth results per client requests, and a failure to thoroughly investigate deviations impacting core manufacturing practices. This encompassed neglecting to determine the cause of microbial growth in environmental controls, uninvestigated temperature/humidity excursions, and numerous unclosed quality events. The company also lacked proper documentation for facility cleaning, failed to validate processes for in-house reagent production, and used testing equipment not proven to yield valid results. Furthermore, procedures for HCT/P donor testing were not consistently established or followed, and records were not maintained concurrently with task performance. Additional issues discussed with management highlighted unaddressed validation problems, inaccurate lot acceptance documentation, overdue equipment maintenance, and an unapproved quality event management procedure at the start of donor testing. Eurofins CellTx Inc. management committed to submitting a written response to the FDA within 15 business days addressing these concerns.