FDA 483 - Concord Biomedical Science and Emerging Technologies, Inc. - May 23, 2019

Concord Biomedical Science and Emerging Technologies, Inc. in Lexington, MA, a nonclinical laboratory, was inspected by the FDA from May 15-23, 2019. The inspection revealed deficiencies related to the archiving of study data and documents, as well as failures to conduct nonclinical laboratory studies in accordance with established protocols. These issues indicate a lack of adherence to good laboratory practices.