Toxicon Violated GLP Regulations: FDA

An 8/13-9/14/21 FDA inspection at Toxikon/Labcorp Bedford, Bedford, MA, conducted under the agency’s Bioresearch Monitoring Program, found violations of the Good Laboratory Practice regulations. A 2/10 Warning Letter says specific violations were: 

•          failure of the study director to assure that all experimental data, including observations of unanticipated responses of the test system, are accurately recorded and verified; and
•          failure of the quality assurance unit to review the final study report to assure that it accurately describes the methods and standard operating procedures and that the reported results accurately reflect the raw data of the nonclinical laboratory study.

The company was told to respond with written documentation of additional actions it has taken or will take to correct the noted violations and prevent their recurrence in current and future studies.