CBER warns Massachusetts-based CRO over GLP issues

A warning letter to Massachusetts-based contract research organization (CRO) Toxikon Corporation earlier this month details good laboratory practice (GLP) violations during the conduct of a nonclinical study.

The warning letter comes just months after the company was acquired by Labcorp and lists multiple GLP violations uncovered during a month-long inspection last summer.

According to the warning letter, the company’s study director failed to assure that all experimental data was accurately recorded and verified. “Multiple mistakes in the study resulted in errors in the calculations of Glomerular Filtration Rate (GFR) and Renal Blood Flow (RBF), which were used in the statistical analysis and reported in the final study report,” FDA wrote in the letter.

These mistakes resulted in most of the GFR values and RBF values from the study to be erroneous. “Because you failed to ensure that all experimental data were accurately recorded and verified, and that all entries and changes in the entries were properly documented, FDA has concerns about the integrity of the data generated from the nonclinical toxicity studies conducted at your testing facility.”

FDA also noted that the company incorrectly calculated urine output values, and while some of the calculations were corrected before the final analysis and inclusion in the summary report, the renal plasma flow (RPF) value for 33 animals was not corrected in time, and the urine output, RPF and RBF values at the 1-hour timepoint for two animals were not corrected properly, FDA said.

The warning letter also cites the company’s quality assurance unit for failing to review the final study report to ensure that it accurately described the methods, standard operating procedures, and raw data of the study.

“A reliable QAU is integral to the successful completion of any GLP study. Without appropriate QAU oversight, the sponsor and FDA reviewers have no assurance that what is reported in the final study report is accurate. Failure to perform QAU functions calls into question the validity of the entire study,” FDA wrote.

Beyond those issues, FDA said its inspection turned up “several additional violations of GLP regulations.” including an instance of the study director failing to ensure proper identification of multiple blood and urine samples and failing to note unforeseen circumstances. FDA said that those issues appear to have been “adequately corrected” based on the company’s response in September 2021.

FDA

CBER warns Massachusetts-based CRO over GLP issues

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