FDA EIR - Eurofins Lancaster Laboratories, Inc - October 21, 2021

An FDA surveillance inspection of Eurofins Lancaster Laboratories, Inc. was conducted from October 20-21, 2021, at their Lancaster, PA facility. Eurofins operates as a contract testing laboratory, providing comprehensive safety testing services for human cells, tissues, and cellular and tissue-based products (HCT/Ps), as well as biological drug products. Their services include microbiology, mycoplasma, genetic stability, viral safety, and biochemistry, applied to various materials such as human tissue (e.g., bone, cartilage, umbilical cord blood) and biopharmaceutical products. The inspection was carried out under regulatory frameworks including CP 7341.002 for HCT/Ps and CP 7345.848 for Biological Drug Products (CBER), focusing on the Quality, Laboratory Control, and Facility/Equipment Systems. The purpose was to confirm that testing, such as sterility, utilized identical USP methods and was performed within a controlled environment with calibrated equipment to ensure uniformity, consistency, reliability, and reproducibility. Crucially, the inspection concluded without any adverse findings; no objectionable conditions were noted, and consequently, a Form FDA 483 was not issued. This indicates that Eurofins Lancaster Laboratories, Inc. demonstrated compliance with applicable regulations, and no specific corrective actions were required from the company based on this report.