FDA 483 - Eurofins Donor & Product Testing LLC - July 19, 2024

Eurofins Donor & Product Testing LLC in Centennial, CO, a RCDAD Laboratory, received a Form 483 with six observations during an FDA inspection. The firm was cited for significant issues including inaccurate microbiology reports, inadequate investigation of deviations related to contamination, and failure to maintain equipment validation records. Additionally, the inspection revealed deficiencies in environmental control, untimely document review for cleaning logs, and facilities not maintained in a good state of repair.