Valley Biosystems – FDA Warning Letter, Oct 8, 2021

The FDA issued a Warning Letter to Valley Biosystems following an inspection from August 26 to October 8, 2021, revealing significant violations of Good Laboratory Practice (GLP) regulations (21 CFR Part 58). The inspection, part of the Bioresearch Monitoring Program, reviewed nonclinical GLP studies.

Key violations include: 1. **Personnel Qualifications and Study Director Responsibilities (21 CFR §§ 58.29(a), 58.29(b), 58.33):** The firm failed to maintain staff training records, assess competency, and ensure the study director was qualified and appointed as the single point of control. The firm's stance that "study director" is a title, not a position, was deemed non-compliant. 2. **Study Director Oversight and Data Integrity (21 CFR § 58.33 (a)(b)(c) and 21 CFR 58.130(e)):** The study director failed to ensure protocol adherence, accurate data recording, and proper documentation of changes. Specifically, animal welfare communications were not documented, and reagent expiration dates were preprinted and altered without explanation, raising concerns about data integrity. 3. **Quality Assurance Unit (QAU) Deficiencies (21 CFR § 58.35(b)(3)):** The QAU failed to maintain complete audit schedules