FDA 483 - Eurofins CellTx Inc - September 20, 2024

Eurofins CellTx Inc in Tucson, AZ, received a Form 483 for significant deficiencies in its RCDAD laboratory operations. Observations included inaccurate client reports, inadequate deviation investigations, poor documentation of cleaning and maintenance, and unvalidated water systems and testing equipment. The findings indicate a systemic lack of control over critical laboratory processes and record-keeping.