Oeyama-Moto-Medical Group Foundation, LLC – FDA Warning Letter, Aug 11, 2017

This Warning Letter details objectionable conditions observed during an FDA inspection of Oeyama-Moto Medical Group Foundation, Inc., from August 7-11, 2017. The inspection reviewed nonclinical laboratory studies of the investigational drug (b)(4), including toxicity studies in mice, rabbits, hamsters, and dogs conducted between 2008 and 2016. The FDA concluded that the facility failed to adhere to statutory requirements and FDA Good Laboratory Practice (GLP) regulations (21 CFR Part 58).

Key violations include: 1. **Lack of Quality Assurance Unit (QAU):** The facility failed to establish an independent QAU to monitor studies, with the study director also claiming to be the QAU head, undermining independence (21 CFR 58.31(c), 58.35(a)). 2. **Absence of Standard Operating Procedures (SOPs):** No written SOPs were established for critical study methods, animal care, or handling (21 CFR 58.81(a) and (b), 58.90). 3. **Inaccurate Data Recording and Verification:** Experimental data was not accurately recorded or verified; entries lacked dates, signatures/initials; and changes obscured original entries without reasons, dates, or signatures (21 CFR 58.33(b), 58.13