Contract Research Organization Draws FDA Warning Letter for GLP Violations
Massachusetts-based Toxikon Corp., a Labcorp subsidiary, has received an FDA warning letter for good laboratory practice (GLP) violations, including multiple observations of inaccurately recorded and verified data.
During an FDA inspection conducted from Aug. 13 to Sept. 14, 2021, investigators found that plasma volume measurements were incorrectly calculated, which adversely affected the readings for certain kidney health indicators.
Because of the company’s failure to ensure the accuracy of all experimental data, the FDA “has concerns about the integrity of the data generated from the nonclinical toxicity studies conducted at your testing facility,” the agency said.
Toxikon could not be reached for comment.