# Warning letters *FDA warning letters issued in May 2021 to two Hennepin Healthcare physicians over ketamine and sedation studies.* In May 2021 the Food and Drug Administration issued warning letters to two physicians at [[Hennepin Healthcare]], the public hospital of [[Hennepin County, Minnesota]]. The letters concerned ketamine and sedation studies on patients that were conducted without the submission of [[Investigational New Drug applications]].[^1] The record documents no other warning letter on this subject. The FDA inspections at Hennepin Healthcare took place in April 2019, twenty-five months before the letters issued.[^2] The record locates no Department of Justice, HHS [[Office for Civil Rights]], or [[Hennepin County Attorney]] action on the studies. It states this as an absence in the public record, not as a documented declination.[^3] ## What The two warning letters were addressed to two individual Hennepin Healthcare physicians. Each concerned ketamine and sedation studies on patients that went ahead without an Investigational New Drug application, the federal filing for an investigational drug trial.[^1] The at-issue record describes the studies as trials on people in crisis, run at the county's public hospital.[^1] ## When The FDA inspected Hennepin Healthcare in April 2019. The warning letters issued in May 2021. That is twenty-five months from inspection to letter, on trials involving the sedation of people in crisis.[^2] ## How many The record counts two warning letters, addressed to two physicians. The project's validation report finds no DOJ or HHS Office for Civil Rights action against Hennepin Healthcare and describes the federal enforcement as "two FDA warning letters only".[^3] The same report lists the absence among the items the package could not verify. It is disclosed as an absence in the record, not as a finding that no action occurred.[^3] The at-issue record adds that no Hennepin County Attorney action on the sedation studies appears in the public record.[^3] The same record documents other federal civil rights action in the county during the period. The Department of Justice opened a pattern-or-practice investigation of the City of Minneapolis and the [[Minneapolis Police Department]] on April 21, 2021, one month before the warning letters issued.[^4] On May 5, 2025 it opened a civil rights investigation, [[DOJ 25-469]], into a policy of the [[Hennepin County Attorney's Office]].[^5] ## In the at-issue record - **Warning letters, May 2021.** Two physicians; ketamine and sedation studies; no Investigational New Drug applications submitted.[^1] - **Inspection to letter, April 2019 to May 2021.** Twenty-five months between the FDA inspections and the warning letters.[^2] - **Enforcement absence.** No Department of Justice, HHS Office for Civil Rights, or Hennepin County Attorney action located. The record reports this as an absence, not a declination.[^3] The at-issue pages for this entry are [[At issue 071 - In May 2021 the FDA issued warning letters]], [[At issue 074 - The FDA inspections at Hennepin Healthcare occurred in]], and [[At issue 075 - No Department of Justice action, no HHS Office]]. ## Notes [^1]: Minnesota wiki at-issue record, *pair AI-Hennepin-071* (source: *Freeman Apex Dossier* §V, Sept. 2, 2026; source kind: agency, fda.gov) — establishes that the FDA issued warning letters in May 2021 to two Hennepin Healthcare physicians for ketamine and sedation studies conducted without Investigational New Drug applications. The FDA letters themselves are not among this pack's citable URLs. [^2]: Minnesota wiki at-issue record, *pair AI-Hennepin-074* (source: *Freeman Apex Dossier* §V, Sept. 2, 2026; source kind: agency, fda.gov) — establishes the FDA inspections in April 2019, the warning letters in May 2021, and the twenty-five-month interval. The FDA inspection records are not among this pack's citable URLs. [^3]: Minnesota wiki, *Validation Report, Hennepin package* §V, item 9, and at-issue *pair AI-Hennepin-075* — establish that no DOJ or HHS OCR action against Hennepin Healthcare was located, that federal enforcement was "two FDA warning letters only", and that no Hennepin County Attorney action appears in the public record. Both state an absence in the record. [^4]: Civil Rights Litigation Clearinghouse, *United States v. City of Minneapolis*, No. 0:25-cv-00048, case record — establishes that the DOJ pattern-or-practice investigation of the City of Minneapolis and MPD opened April 21, 2021. https://clearinghouse.net/case/18178/ [^5]: U.S. Department of Justice, *U.S. Department of Justice Announces Civil Rights Investigation into the Consideration of Race in Prosecutorial Decision making by Minnesota's Hennepin County* (May 5, 2025, release 25-469) — establishes the opening of the investigation. https://www.justice.gov/opa/pr/us-department-justice-announces-civil-rights-investigation-consideration-race-prosecutorial