FDA EIR - VRL Eurofins - August 26, 2020

An FDA inspection of VRL Eurofins in Waltham, MA, was conducted from August 25-26, 2020. This facility operates as a human tissue establishment, specializing in serological testing for organ banks and human tissue establishments across New England. VRL Eurofins is registered with the USFDA to screen donors of cornea, sperm, egg, musculoskeletal, and soft tissues for various infectious agents including HIV, Hepatitis B and C, and West Nile Virus.

The inspection followed the regulatory framework outlined in CPGM 7341.002 for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), and incorporated specific guidance from PAC 45R913 and Field Alert#57 for conducting activities during the COVID-19 pandemic. During the review, investigators examined the firm’s standard operating procedures, quality control documentation, equipment validation, and serological testing files, also observing testing processes.

Crucially, the inspection identified no main violations or issues. As a result, an FDA-483, which details objectionable conditions, was not issued to VRL Eurofins’ management. No specific corrective actions were required, though management received a general reminder regarding their ongoing responsibility to comply with all applicable laws and regulations.