FDA 483 - University of Massachusetts Incorporated - November 01, 2022

An FDA inspection of University of Massachusetts Incorporated in Worcester, MA, a QC Laboratory, revealed significant deficiencies in quality control unit responsibilities, laboratory record-keeping, and equipment maintenance. The firm failed to qualify an animal supplier for cGMP testing and lacked proper tracking for in-process samples. Additionally, laboratory records were not reviewed by a second person, and preventative maintenance procedures for critical equipment were not followed as established.