FDA WARNING_LETTER - US Stem Cell Clinic, LLC - May 11, 2017

The FDA issued a Warning Letter to US Stem Cell Clinic, LLC (USSC) following an inspection from April 10 to May 11, 2017. The inspection revealed that USSC recovers and processes adipose tissue into stromal vascular fraction (SVF) for autologous use, administered intravenously or intrathecally, to treat various conditions including Parkinson's, ALS, and heart disease. The FDA determined that USSC's SVF product is an unapproved drug and biological product under the FD&C Act and PHS Act, as it does not meet the minimal manipulation or homologous use criteria for regulation solely as an HCT/P.

The letter cited significant deviations from current Good Manufacturing Practice (CGMP) and Good Tissue Practice (CGTP), many of which were similar to observations from a previous 2015 inspection. Key violations included: failure to validate aseptic processes and prevent microbiological contamination (e.g., lack of validation, dust accumulation, improper disinfectants), failure to validate the manufacturing process, inadequate laboratory testing (e.g., sterility and endotoxin testing), insufficient environmental monitoring, lack of written procedures for equipment cleaning/maintenance, inadequate equipment records, improper personnel gowning (non-sterile masks/caps), lack of final product testing specifications, failure to establish acceptance criteria and procedures for components, use of unreleased components (e.g., "research use only" reagents), absence of a quality control unit, incomplete batch production