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# 2 FDA-483s Issued to Clinical Investigators
- URL: https://www.fdaweb.com/2-fda-483s-issued-to-clinical-investigators/
- Published: 2021-05-10T12:00:00.000Z
- Updated: 2026-09-14T16:58:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149281

FDA has released two 2019 Form FDA-483s after inspecting two Hennepin County Medical Center (Minneapolis, MN) clinical investigators who were cited for study violations.

The [first FDA-483](https://www.fda.gov/media/148242/download?ref=fdaweb.com) went to sponsor investigator **Lauren Klein**, who was cited for failing to submit an IND to FDA for conducting a clinical investigation with an investigational new drug. She was also cited for not obtaining informed consent and for not obtaining IRB approval for all changes in research activity. Additionally, Klein was not following the study plans, according to the FDA-483.

The [second FDA-483](https://www.fda.gov/media/148243/download?ref=fdaweb.com) was issued to clinical investigator **John Cole**, who was cited for similar violations. The inspection form also took issue with Cole for not ensuring study monitoring was appropriate. Additionally, Cole was cited because the investigational drug disposition records were not adequate, specifically the dates, quantity and use by subjects were not maintained.