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Evidence page

Warning Letter: US Stem Cell Clinic, LLC (524470)

U.S. Food and Drug Administration

Published Aug 24, 2017accessed Sep 18, 2026Updated Sep 19, 2026

Original source

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/us-stem-cell-clinic-llc-524470-08242017

fda.gov

Verification

Verification	Not yet verified
Evidence level	—
Source	government
Link status	Reachable at last check

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Cited by (2)

FactSVF Breast Augmentation: US FDA position = Adipose-derived SVF fails the minimal-manipulation criterion (21 CFR 1271.10(a)(1)) and needs an IND or an approved BLA as a drug/biologic FactSVF Facial Fat Grafting: US regulatory position = FDA stated that processing adipose tissue into SVF is more than minimal manipulation, that the same-surgical-procedure exception does not apply, and that a BLA or IND is required