Testing Center of Sanitation & Environment Technic Institute – FDA Warning Letter, Jun 3, 2011

The FDA issued a Warning Letter to Testing Center of Sanitation & Environment Technic Institute following a May 30 - June 3, 2011 inspection. The inspection, part of the Bioresearch Monitoring Program, assessed compliance with 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies) for studies supporting 510(k) supplements for medical devices.

Violations included: 1. **Study Director Responsibilities (21 CFR 58.33(a) and (f), 58.120):** Failure to ensure approved written protocols existed prior to study initiation and to ensure all documentation and protocols were transferred to archives. The company's response was inadequate, lacking SOPs, implementation dates, training dates, and staff lists. 2. **Final Study Report (21 CFR 58.185):** The final report for study (b)(4) lacked required documentation (statistical methods, signed pathology reports, personnel names) and corrections were made by issuing new reports instead of amendments. The company's response lacked a timeline for new reports for current studies. 3. **Quality Assurance Unit (QAU) (21 CFR 58.35(b)(1) and (7)):** Failure to maintain a master schedule sheet and include a QAU statement in final reports. The company's response was inadequate, lacking new/revised SOPs