Colorado Histo-Prep – FDA Warning Letter, May 10, 2013

The FDA issued a Warning Letter to Colorado Histo-Prep following an inspection from April 10 to May 10, 2013, which reviewed nonclinical laboratory studies for (b)(4). The inspection, part of the Bioresearch Monitoring Program, found violations of 21 CFR Part 58 Good Laboratory Practice (GLP) regulations.

Key violations include: 1. **Quality Assurance Unit (QAU) Deficiencies:** The QAU failed to ensure that no unauthorized deviations from protocols or SOPs occurred, specifically regarding tissue substitutions and missing tissues in Studies (b)(4) and (b)(4). The QAU also failed to maintain independence from study conduct, with the QA Manager receiving and auditing tissue shipments, performing post-study checkouts, and engaging in study planning. 2. **Inaccurate Reporting:** The QAU failed to ensure final study reports accurately reflected raw data. For example, tissues reported as "No Significant Findings" were never processed, hematology parameters did not match raw data, and clinical chemistry samples were reanalyzed without justification. 3. **SOP Adherence and Data Handling:** Not all deviations from SOPs were authorized and documented. The QAU failed to inspect clinical pathology raw data and review statistical reports. The facility lacked SOPs for handling, storage, and retrieval of electronic data, including security and audit trails for statistical analyses. 4. **Equipment Maintenance:** Reagents in the Tissue Tek