FDA 483 - U.S. Army Medical Research Institute of Infectious Diseases - February 03, 2020

The FDA inspected the U.S. Army Medical Research Institute of Infectious Diseases, a nonclinical laboratory in Ft. Detrick, MD. The inspection revealed significant issues concerning the conduct of Animal Rule studies, including the failure to retain complete raw data, deviations from study protocols, and inaccuracies in recording and verifying experimental data. These findings indicate deficiencies in data integrity and adherence to established research procedures.