# FDA 483 - Spaulding Clinical Research - November 16, 2023

Source: https://www.keypedia.com/records/483/spaulding-clinical-research/54c4c86f-7f87-4c6b-a9b9-80d42a82e79c

> FDA 483 for Spaulding Clinical Research on November 16, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Spaulding Clinical Research
- Inspection Date: 2023-11-16
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: 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.

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Company: https://www.keypedia.com/companies/spaulding-clinical-research/06122614-ceda-4378-992e-98fd27bfc12d

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d