FDA WARNING_LETTER - SNBL USA LTD. - November 20, 2009

This FDA Warning Letter, dated August 9, 2010, addresses SNBL USA, Ltd. following inspections on July 21-August 1, 2008, and November 16-20, 2009, as part of the Bioresearch Monitoring Program. The inspections revealed significant non-compliance with 21 CFR Part 58, Good Laboratory Practice (GLP) regulations for nonclinical laboratory studies.

Key violations include: 1. **Testing Facility Management failures:** Not ensuring personnel understood final report preparation (leading to unsigned draft reports being used), failing to ensure test article mixture stability testing, and not implementing adequate SOPs for sterile preparation and biological safety cabinet maintenance. 2. **Study Director failures:** Repeatedly preparing draft final reports without necessary raw data, failing to verify toxicokinetics reports, and not ensuring accuracy of bioanalytical methods (e.g., lack of quality control samples, not rejecting runs exceeding limits, using invalid methods, selectively excluding aberrant results). 3. **Quality Assurance Unit failures:** Not maintaining an accurate master schedule sheet and failing to ensure no unauthorized/undocumented deviations from SOPs (e.g., overdue facility inspections, outdated SOPs in use, incomplete staff training, uncalibrated equipment). 4. **Final Report deficiencies:** Study Directors failing to sign and date final reports, and not making corrections/additions to final reports via amendments.

The FDA noted that