FDA Cites 'Significant Deviations' at Florida Stem Cell Clinic

Share this content:
FDA Cites 'Significant Deviations' at Florida Stem Cell Clinic
FDA Cites 'Significant Deviations' at Florida Stem Cell Clinic

TUESDAY, Aug. 29, 2017 (HealthDay News) -- A Florida stem cell clinic has received a warning letter from the U.S. Food and Drug Administration about what the agency describes as serious problems that could pose health risks to patients.

The agency said Monday that it has cited U.S. Stem Cell Clinic, of Sunrise, for marketing stem cell products without FDA approval and for "significant deviations from current good manufacturing practice requirements," including some that could affect the "sterility of their products, putting patients at risk."

The FDA said it hasn't approved any biological products made by U.S. Stem Cell Clinic for any use.

"Stem cell clinics that mislead vulnerable patients into believing they are being given safe, effective treatments that are in full compliance with the law are dangerously exploiting consumers and putting their health at risk," FDA Commissioner Scott Gottlieb, M.D., said in an agency news release. "As the FDA takes new steps to advance an efficient, modern approach to the regulation of cell-based regenerative medicine, at the same time we will be stepping up our enforcement actions against clinics that abuse the trust of patients and, more important, endanger their health with unsanitary conditions or by purporting to have treatments which may not provide any benefit."

More Information

Share this content:

is free, fast, and customized just for you!

Already a member?

Sign In Now »


Sign up for myCME e-newsletters


Drug Lookup

Browse drugs by: BrandGenericDisease

Trending Activities

All Professions

More in Home

Air Pollution May Damage Kidneys

Air Pollution May Damage Kidneys

Study finds link between particulate matter and renal function

Diabetes Treatment Failure May Actually Be Nonadherence

Diabetes Treatment Failure May Actually Be Nonadherence

Second-line treatment often initiated without evidence of recommended use of first-line treatment

Effect of Osteoporotic Fractures Similar to Diabetes Burden

Effect of Osteoporotic Fractures Similar to Diabetes Burden

Findings for quality of life with hip fractures, vertebral compression vs. vision loss, amputation

is free, fast, and customized just for you!

Already a member?

Sign In Now »