FDA 483 - Samm Solutions, Inc (dba) BTS Research - July 08, 2012

The FDA conducted an inspection of Samm Solutions, Inc (dba) BTS Research, a GLP facility/CRO, from June 27 to July 8, 2022, resulting in a Form FDA 483 issued on July 21, 2022. This document outlined nine significant observations, some being repeat violations, indicating non-compliance with Good Laboratory Practices (GLP) regulations.

Key issues included studies not being conducted according to protocol, such as improper test article storage conditions and unauthorized repeat dosing. The facility also lacked adequate written standard operating procedures (SOPs) for laboratory methods, impacting data quality and integrity. A major concern highlighted was the Study Director's failure to maintain overall responsibility for technical study conduct, interpretation, analysis, documentation, and reporting, including insufficient archival of communications and lack of documented review for analytical results.

Additionally, the Quality Assurance Unit failed to properly authorize and document protocol deviations and did not ensure final study reports accurately reflected raw data, citing numerous discrepancies. Reports also omitted descriptions of circumstances affecting data quality, and critical study records were not properly transferred to archives, which themselves were disorganized and lacked expedient retrieval. Finally, test and control articles in final reports lacked complete and substantiated identification details.

Samm Solutions, Inc. must address these observations by implementing comprehensive corrective actions to ensure strict adherence to protocols and GLP standards, enhance SOPs, clarify Study Director responsibilities, improve Quality Assurance oversight, and establish robust documentation and archival practices to guarantee data integrity and traceability.