FDA 483 - US Stem Cell Clinic, LLC - December 07, 2015
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This FDA Form 483 details significant deficiencies observed at US Stem Cell Clinic, LLC in Sunrise, FL, during an inspection of its autologous Stromal Vascular Fraction (SVF) manufacturing operations. The firm was cited for numerous failures in aseptic processing, quality control, laboratory controls, record-keeping, and equipment management, indicating a severe lack of adherence to good manufacturing practices. These issues raise concerns about the sterility, identity, strength, quality, and purity of the SVF product administered to patients.
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