FDA WARNING_LETTER - sanitation & environmental technology institute - March 15, 2024

The FDA issued a Warning Letter to Sanitation & Environmental Technology Institute (dba SDWH), Ltd. following an inspection from March 6-15, 2024, which revealed serious violations of 21 CFR Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies. The inspection focused on GLP nonclinical studies for device development, including guinea pig sensitization, acute systemic toxicity, complement activation, hemolysis, and cytotoxicity tests.

Key violations include: 1. **Study Director Failures (21 CFR 58.33):** The study director failed to ensure protocol adherence, accurate data recording/verification, documentation of unforeseen circumstances and corrective actions, and proper archiving of raw data and study materials. Examples include unreported data, inability to attribute raw data to specific samples, failure to follow testing protocols (e.g., absorbance measurements), and incomplete archiving of computer-generated raw data. A significant issue was the unapproved change in test material description in a final report without proper documentation. 2. **Testing Facility Management Failures (21 CFR 58.31):** Management failed to ensure a functioning Quality Assurance Unit (QAU) and that QAU-reported deviations were communicated and corrected. Issues included inadequate investigations into data duplication, insufficient training for QAU and study directors, and QAU reports not being submitted periodically but only at final report signing. 3. **QAU Responsibilities Failures (21 CFR 58