FDA 483 - StemGenex Biologic Laboratories, LLC - January 26, 2018

An FDA inspection of StemGenex Biologic Laboratories, LLC in San Diego, CA, revealed significant deficiencies in the manufacturing of their autologous, injectable Stromal Vascular Fraction (SVF) product. The firm failed to validate manufacturing and aseptic processes, lacked environmental monitoring, and had inadequate laboratory controls and quality unit oversight. These serious issues indicate a systemic failure to adhere to current Good Manufacturing Practices, potentially compromising product quality and patient safety.