FDA WARNING_LETTER - Toxikon Corporation/Labcorp Bedford LLC - September 14, 2021

This Warning Letter, CBER-22-001, dated February 10, 2022, informs Dr. Desai of objectionable conditions observed during an FDA inspection from August 13 to September 14, 2021, regarding a nonclinical GLP study. The inspection, under the Bioresearch Monitoring Program, found violations of 21 CFR Part 58 – Good Laboratory Practice (GLP) regulations.

Key violations include the study director's failure to ensure accurate recording and verification of experimental data [21 CFR § 58.33(b)]. Specifically, there were multiple errors in Glomerular Filtration Rate (GFR) and Renal Blood Flow (RBF) calculations due to an incorrect plasma volume formula, affecting 32 of 34 GFR values and 133 of 136 RBF values. Additionally, urine output values at the one-hour timepoint were incorrectly calculated, leading to subsequent errors in RPF, RBF, and GFR values for numerous animals, with some errors not corrected in the final report.

The Quality Assurance Unit (QAU) failed to review the final study report accurately, missing calculation errors and uncorrected urine output issues [21 CFR § 58.35(b)(6)]. This calls into question the validity of the entire study. Other violations included improper sample identification, inadequate documentation of concentrations/dilutions, and