FDA 483 - PharmaLegacy Research LLC - June 21, 2019

An FDA inspection of Samm Solutions, Inc. (dba BTS Research) in San Diego, CA, a non-clinical laboratory, revealed significant deficiencies across multiple studies. The firm failed to adhere to study protocols, properly archive raw data, document and authorize deviations, and ensure the accuracy of experimental data. These issues indicate a systemic lack of control and oversight in their GLP-regulated non-clinical laboratory studies.