FDA EIR - Eurofins Lancaster Laboratories, Inc - September 13, 2019

An FDA surveillance inspection of Eurofins Lancaster Laboratories, Inc. was conducted from September 12-13, 2019, in Lancaster, PA. This inspection focused on the company's contract testing services for human tissues, including bone, cartilage, ligaments, skin, tendons, autologous somatic cell therapy products, and umbilical cord blood. The inspection was performed under the regulatory framework of CP 7341.002, "Inspection of Human Cells, Tissues and Cellular and Tissue Based Products (HCT/Ps)," as part of the OBPO Division 1/Group 3’s FY19 workplan.

During the two-day review, the FDA investigator observed the firm's operations, including the receipt and processing of human tissue samples for bioburden testing, sample storage, and the transition to a new in-house developed lab information computer system. The inspection involved reviewing standard operating procedures, validation documentation, investigation reports, deviation records, equipment maintenance and calibration, and environmental and temperature monitoring data.

Significantly, the inspection concluded without any adverse findings. No FDA-483, Inspectional Observations, were issued, and no discussion items requiring follow-up were raised. Consequently, no corrective or required actions were mandated by the FDA.