FDA 483 - PharmaLegacy Research LLC - July 08, 2022

An FDA inspection of Samm Solutions, Inc (dba) BTS Research, a GLP Facility/CRO in San Diego, CA, revealed significant deficiencies in the conduct and documentation of nonclinical laboratory studies. The firm failed to adhere to study protocols, maintain adequate standard operating procedures, and ensure proper oversight by study directors and the quality assurance unit. These systemic issues compromised data integrity, led to inaccurate final reports, and resulted in disorganized archiving practices.