FDA EIR - Eurofins Lancaster Laboratories, Inc - June 19, 2015

An FDA surveillance inspection of Eurofins Lancaster Laboratories, Inc. in Lancaster, PA, was conducted from June 18 to June 19, 2015. This routine inspection focused on evaluating the contract laboratory's adherence to Current Good Manufacturing Practices (cGMP), specifically under the regulatory frameworks of Drug Process Inspections (CP 7356.002) and Animal Drug Inspections (CP 7371.001). The inspection comprehensively covered the firm's Quality, Laboratory, and Facility and Equipment Systems. This included a review of standard operating procedures, sterility and endotoxin testing, the stability program, method validation studies, analytical test reports, sample handling, reporting of results, raw data, and instrument qualification and maintenance. Additionally, critical testing operations were inspected on-site. Notably, the inspection concluded without any significant observations or findings of non-compliance. Consequently, no Form FDA 483, which lists objectionable conditions, was issued to the company. Therefore, no specific regulatory violations or corrective actions were required from Eurofins Lancaster Laboratories, Inc. at the close of this inspection.