483
U.S. Army Medical Research Institute of Infectious DiseasesU.S. Army Medical Research Institute of Infectious Diseases – FDA 483, Feb 3, 2020
Record Details
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.
- Inspection date
- February 3, 2020
- Product type
- biologics
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