FDA 483 - Founders Science Group, LLC - May 17, 2022

Founders Science Group, LLC, a contract testing laboratory in Taunton, MA, was cited for not establishing and documenting the accuracy, sensitivity, specificity, and reproducibility of its test methods. The firm was found to be unprepared to support the commercial manufacture of a drug product due to a lack of validated analytical methods. This indicates a significant deficiency in their quality control and testing capabilities.