FDA WARNING_LETTER - Samm Solutions, Inc., d.b.a. BTS Research - July 08, 2022

The FDA issued a Warning Letter to Samm Solutions, Inc., d.b.a. BTS Research, following an inspection from June 27 to July 8, 2022, under the Bioresearch Monitoring Program. The inspection revealed significant violations of Good Laboratory Practice (GLP) regulations (21 CFR Part 58) concerning nonclinical laboratory studies.

Key violations include: 1. **Study Director Failures (21 CFR 58.33(b) and (c))**: Study directors for Protocols (b)(4) and (b)(4) failed to accurately record and verify experimental data, specifically clinical pathology results. They also failed to document unforeseen circumstances (e.g., reagent unavailability, equipment malfunction, insufficient samples) that affected study quality and integrity. Discrepancies between raw data and final reports were noted. 2. **Deviation Management and Reporting (21 CFR 58.81(a), 58.185(a)(9))**: Study directors failed to authorize and document all deviations from SOPs and protocols in raw data and final reports. Examples include unrecorded eye examinations, incorrect batch numbers, out-of-range formulation analysis, unrecorded refrigerator temperatures, unlogged archival submissions, and missing tissues at necropsy. 3. **Quality Assurance Unit (QAU) Deficiencies (21 CFR 58.35(b)(6))