FDA EIR - Eurofins Lancaster Laboratories, Inc - September 28, 2017

An FDA surveillance inspection of Eurofins Lancaster Laboratories, Inc. in Lancaster, PA, occurred from September 25 to September 28, 2017. The inspection aimed to assess compliance with Current Good Manufacturing Practices (cGMP) for drug processes and regulations for human tissue (HCT/Ps) microorganism testing, guided by Compliance Programs 7356.002 and 7341.002, respectively. Investigators thoroughly examined the company's Quality, Laboratory, and Facility and Equipment Systems. Key areas of focus included qualification activities for the stability program and cell banking operations, with a review of associated reports, media fills, deviation records, and method transfer documentation. For HCT/Ps, the inspection focused on processes related to the receipt and microorganism testing of human tissues and bone, scrutinizing processing records, quality assurance documentation, equipment maintenance, and standard operating procedures. Crucially, the inspection concluded with no significant observations. No FDA Form 483 (Inspectional Observations) was issued, and no discussion items were noted, indicating that Eurofins Lancaster Laboratories, Inc. was found to be operating in compliance with the applicable regulatory requirements during this surveillance.