FDA 483 - Toxicology Research Laboratory - March 07, 2025

The FDA issued a Form 483 to Toxicology Research Laboratory in Chicago, citing significant deficiencies in data integrity and reporting practices during non-clinical studies. Observations included the study director's failure to accurately record and verify experimental data, as well as the final study reports lacking descriptions of circumstances that affected data quality or integrity. These issues indicate a serious breakdown in ensuring reliable and complete study documentation.