Spaulding Clinical ResearchNovember 16, 2023

FDA 483 - Spaulding Clinical Research - November 16, 2023

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An FDA inspection of Spaulding Clinical Research in West Bend, WI, a BIMO Clinical Investigator, identified a significant issue regarding informed consent documents. The inspection revealed that informed consent forms for a specific study lacked descriptions of reasonably foreseeable risks or discomforts, did not accurately list the number of blood draws, and omitted details about IV catheter placement, indicating a serious deficiency in subject protection.

Company: Spaulding Clinical Research
Inspection Date: November 16, 2023
Product Type: Drugs
Office: Minneapolis District Office
Person: Denise L. Burosh (Bioresearch Monitoring Specialis)

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ID · 54c4c86f-7f87-4c6b-a9b9-80d42a82e79c