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

U.S. Food and Drug Administration

Published Aug 24, 2017accessed Nov 10, 2026Updated Nov 10, 2026
Original source

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

fda.gov

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Cited by (7)

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/biologicFactSVF 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 requiredAnswer日本では同じSVF豊胸を受けられますか？厚生労働省やPMDAの扱いはどうなっていますか？AnswerアメリカではSVFが規制されていると聞きましたが、どういう経緯ですか？AnswerSVF 가슴성형은 한국에서 합법인가요? 첨단재생의료 규제를 받나요?Answer这种SVF干细胞丰胸在中国大陆的正规医院能做吗？国内是怎么管的？Answerسمعت أن SVF ممنوع في الولايات المتحدة، فما القصة وهل ينطبق الأمر على السعودية والإمارات؟