FDA 483 - Labcorp Bedford LLC. - January 24, 2019

An FDA inspection of Toxikon Corporation, a nonclinical laboratory in Bedford, MA, revealed two significant issues. The firm failed to ensure laboratory manuals and standard operating procedures were immediately available, specifically in the native language of non-English speaking animal care technicians. Additionally, animal cages and equipment were not cleaned and sanitized at appropriate intervals, with technicians observed refilling used food barrels in a dirty corridor.