483
AbbottFDA 483 - Abbott - June 28, 2024
Record Details
An FDA inspection of Abbott in Plymouth, MN, identified significant deficiencies in its role as a sponsor-monitor for an investigational study. Observations included failures to ensure the timely return of investigational devices from non-compliant investigators and delays in recognizing and acting upon serious non-compliance. Additionally, the firm submitted incomplete and inaccurate annual progress reports to the FDA and IRBs, indicating concerns with clinical trial oversight and regulatory reporting.
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ID · 8b0ccfe2-c4a9-4369-9c8f-e59c50f30888