# FDA WARNING_LETTER - BioStem Life Sciences - September 15, 2023

Source: https://www.globalkeysolutions.net/records/warning_letter/biostem-life-sciences/a7e95498-e152-4e44-a1c5-8519c8a02ef8

> FDA WARNING_LETTER for BioStem Life Sciences on September 15, 2023. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: BioStem Life Sciences
- Inspection Date: 2023-09-15
- Product Type: Biologics
- Office Name: Center for Biologics Evaluation and Research
- Summary: 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.

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/melissa-j-mendoza/681d7777-4f19-4ecc-b31d-3272cb275c77)

Company: https://www.globalkeysolutions.net/companies/biostem-life-sciences/4176f89f-ddd4-4fb5-8acb-833a79139efd

Office: https://www.globalkeysolutions.net/offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d