FDA EIR - Eurofins Lancaster Laboratories, Inc - October 17, 2019

An FDA abbreviated surveillance inspection of Eurofins Lancaster Laboratories, Inc., a contract testing laboratory, was conducted from October 15 to October 17, 2019. This inspection, part of the PHARM 1 IBII FY20 work plan, adhered to Compliance Program 7356.002 for Drug Manufacturing Inspections and Compliance Program 7371.001 for Animal Drug Manufacturing Inspections. The previous inspection on September 13, 2019, was classified as No Action Indicated (NAI).

The current assessment focused on the company's Quality, Laboratory, and Facility and Equipment Systems. Eurofins Lancaster Laboratories provides a broad array of services for the Pharmaceutical and Biopharmaceutical industry, including cell banking, raw materials testing, release testing, and stability testing. During the three-day inspection, investigators performed walkthroughs of laboratories, observed analysts, and reviewed training programs, standard operating procedures (SOPs), investigations, and complaint handling processes.

Crucially, the inspection concluded with no significant observations or issues identified. Consequently, no FDA Form 483, which details objectionable conditions, was issued, and no samples were collected. The facility was found to be operating in compliance with the relevant regulatory frameworks, and no specific corrective actions were required.