Skye Biologics Holdings LLC – FDA Warning Letter, Dec 9, 2022

The FDA inspected the facility at 2255 Campus Dr, El Segundo, CA, from November 29 to December 9, 2022, regarding the manufacture of "placental connective tissue matrix allograft" products, specifically BioECM™. The FDA determined these products are unapproved new drugs and unlicensed biological products, violating sections 505(a) and 301(d) of the FD&C Act, and 351(a) of the PHS Act.

The products are considered drugs and biological products because they are intended for disease treatment/prevention or to affect body structure/function. They are also Human Cells, Tissues, or Cellular or Tissue-Based Products (HCT/Ps) but do not meet the criteria for regulation solely under section 361 of the PHS Act. Specifically, they fail the "minimal manipulation" criterion (21 CFR 1271.10(a)(1)) as processing alters the umbilical cord's original characteristics, and the "homologous use only" criterion (21 CFR 1271.10(a)(2)) as their intended uses (e.g., inflammation modulation, tissue remodeling) are not basic functions of the umbilical cord. Therefore, a valid Biologics License Application (BLA) is required, which is not in effect.

Additionally, significant Current Good Manufacturing Practice (CGMP) violations