FDA 483 - AB Science

AB Science, a sponsor located in Paris, France, was inspected by the FDA from September 22-26, 2014, and received a Form 483 with three observations. The inspection revealed significant deficiencies in the monitoring of clinical investigations, including inadequate safety reporting, untimely data submission, and missing monitoring visit reports. Additionally, the firm failed to provide proper training to clinical investigators and did not ensure timely reporting of serious adverse events as required by study protocols.