FDA 483 - Eurofins BioPharma Product Testing Toronto, Inc. - November 15, 2019

Eurofins Experchem Laboratories Inc., a contract testing laboratory in North York, Ontario, was cited for significant deficiencies during an FDA inspection. The firm demonstrated a pattern of inadequate Out of Specification (OOS) investigations, frequently invalidating results without scientific justification or thorough root cause analysis. Additionally, the inspection revealed a severe lack of Quality Unit oversight over controlled documents and incomplete laboratory records, indicating serious data integrity concerns.