FDA WARNING_LETTER - BioStem Life Sciences - September 15, 2023

The FDA inspected Biostem Life Sciences (Pompano Beach, FL) from September 11-15, 2023, finding significant violations of current good manufacturing practice (CGMP) requirements for their cellular products (OROPRO®, PROVISCUS®, NEOFYL®) and amniotic membrane product (RHEO®). These products, derived from human umbilical cord and amniotic membrane, are deemed drugs and biological products under the FD&C Act and PHS Act, respectively, and are also Human Cells, Tissues, or Cellular or Tissue-Based Products (HCT/Ps).

The products fail to meet HCT/P criteria for minimal manipulation and homologous use, thus requiring an approved Biologics License Application (BLA), which Biostem Life Sciences lacks.

Violations include: 1. **Inadequate environmental monitoring:** Failure to perform routine non-viable particulate monitoring and surface sampling in critical aseptic processing areas, and lack of microbiological monitoring for operator arm coverings. 2. **Unvalidated cleaning and disinfection:** Failure to validate cleaning and disinfection procedures for ISO 5 and ISO 7 cleanrooms. 3. **Inadequate production and process controls:** Manufacturing processes are not adequately validated for identity, strength, quality, and purity, with testing limited to insufficient measures. 4. **Insufficient laboratory controls:** Final product testing is limited to sterility and endotoxin, not demonstrating identity or strength.