Irvine Stem Cell Treatment Center – FDA Warning Letter, Sep 19, 2015

The FDA issued a Warning Letter to Thomas A. Gionis, MD, JD, MPH, MBA, MHA, LLM, FICS, FAIHQ, owner of Irvine Stem Cell Treatment Center (CA), Miami Stem Cell Treatment Center (FL), and Manhattan Regenerative Medicine Medical Group (NY), following inspections from July to September 2015.

The FDA determined that the firms recover and process adipose tissue into stromal vascular fraction (SVF) for autologous use, intended to treat various diseases including autism, Parkinson's, COPD, and MS. The FDA classified SVF as a drug and biological product under the FD&C Act and PHS Act, and an HCT/P under 21 CFR 1271.3(d). The SVF product does not meet criteria for regulation solely under section 361 of the PHS Act and 21 CFR Part 1271 because its processing constitutes more than minimal manipulation and it is not for homologous use. Therefore, a valid biologics license or an Investigational New Drug (IND) application is required for lawful marketing, neither of which is in effect.

The inspections also revealed significant deviations from current Good Manufacturing Practice (CGMP) and current Good Tissue Practice (CGTP) from February 2013 to August 2015. Key violations include: 1. Failure to establish and follow written procedures to prevent microbiological contamination of sterile drug products