FDA 483 - VRL Eurofins - July 18, 2025

Eurofins Donor & Product Testing, LLC, located in San Ramon, California, underwent an FDA inspection from July 14 to July 18, 2025. As a laboratory specializing in testing donors for communicable diseases, the facility was issued a Form 483 due to several significant operational deficiencies. The primary issues identified involve failures in record-keeping, procedural compliance, and data integrity.

Specifically, investigators found that the lab did not retain required records for the mandated ten-year period. This included discarding original test records for invalidated runs involving HIV and Hepatitis. Furthermore, staff were observed deviating from manufacturer instructions by using incorrect container types for reagent preparation. Documentation practices were also deemed inadequate; essential details such as the identity of personnel, specific equipment used for centrifugation, and descriptions of corrective actions were frequently missing. Most notably, the inspection revealed inaccuracies in data entry, where technologists recorded incubation times on temporary notes and later entered different, incorrect times into the official laboratory information system.

These observations were conducted under the regulatory framework of the Federal Food, Drug, and Cosmetic Act. While the Form 483 does not represent a final agency determination, the company is expected to respond to the FDA with a detailed plan of corrective actions to address these violations and ensure the accuracy and reliability of their donor testing processes.