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483
•Element Research Group Inc.•June 26, 2026

Element Research Group Inc. – FDA 483, Jun 26, 2026

Record Details

An FDA inspection of Element Research Group Inc., a nonclinical laboratory in Brooklyn Park, MN, revealed three significant observations. The firm's study director failed to ensure adherence to GLP regulations, proper recording and verification of experimental data, and adequate documentation of protocol changes. These issues indicate deficiencies in the conduct and oversight of studies.

Company
Element Research Group Inc.
Inspection date
June 26, 2026
Product type
other
Office
Minneapolis District Office
Person
  • Yuanyuan Li (issuing_officer)
View Company Profile

ID · 94305251-037b-4379-836e-fcfdfdc34954

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