IntelliCell Biosciences, Inc. – FDA Warning Letter, Dec 12, 2011

This FDA Warning Letter, dated March 13, 2012, to IntelliCell Biosciences, Inc., details violations observed during an inspection from November 8 to December 12, 2011. IntelliCell processes adipose tissue into "IntelliCell™" (adipose-derived stem cells) for autologous use, administered intravenously or injected for various conditions like osteoarthritis, gum recession, and cosmetic purposes.

The FDA determined IntelliCell's product is a human cell, tissue, or cellular and tissue-based product (HCT/P) but does not meet criteria for regulation solely under Section 361 of the PHS Act (21 CFR 1271.10(a)). Specifically, the processing alters relevant characteristics, failing the "minimal manipulation" definition (21 CFR 1271.10(a)(1)). Additionally, many uses are not "homologous use" (21 CFR 1271.3(c)). Consequently, IntelliCell's product is classified as a drug and biological product requiring an approved biologics license application (BLA) or an investigational new drug (IND) application, neither of which is in effect.

The letter also cites significant deviations from current good manufacturing practice (CGMP) and current good tissue practice (CGTP) from August 2010 to November 2011, violating 21 CFR Parts 2