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# Florida Court Order Shuts Down Stem Cell Clinics
- URL: https://www.fdaweb.com/florida-court-order-shuts-down-stem-cell-clinics/
- Published: 2019-06-25T12:00:00.000Z
- Updated: 2026-09-15T01:34:51.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5144416

A Florida federal court 6/25 has issued an order that stops U.S. Stem Cell Clinic, of Weston, FL, and U.S. Stem Cell Inc., of Sunrise, FL, and their chief scientific officer **Kristin Comella**, from manufacturing or distributing any and all stromal vascular fraction products, which are adipose (fat) tissue derived stem cell products, until they come into compliance with the law. The order follows a 6/3 FDA motion for summary judgment that was granted by the court over adulterating and misbranding a stem cell drug product made from a patient’s adipose tissue.

In a 2017 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/us-stem-cell-clinic-llc-524470-08242017?ref=fdaweb.com), FDA said the clinic was marketing stem cell products without FDA approval and cited significant deviations from current good manufacturing practice regulations following an agency inspection that found the company was administering its product intravenously or via other methods of administration to treat a variety of serious diseases or conditions. FDA says it has not approved any biological products manufactured by U.S. Stem Cell Clinic for any use. The clinic also was cited for failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile.

“Court decisions like this reaffirm the FDA’s compliance and enforcement efforts in the ongoing fight to protect the public from individuals and clinics who mislead patients with unapproved and potentially harmful medical products,” an [agency release](https://www.fda.gov/news-events/press-announcements/statement-stem-cell-clinic-permanent-injunction-and-fdas-ongoing-efforts-protect-patients-risks?ref=fdaweb.com) says. “The agency will continue to take steps — such as issuing Warning Letters or initiating court cases — against those who endanger patients’ health with inadequate manufacturing conditions or by manufacturing and marketing products without the submission of appropriate applications containing safety and efficacy information to the FDA.”