# FDA WARNING_LETTER - Evolutionary Biologics Inc. - January 28, 2025

Source: https://www.globalkeysolutions.net/records/warning_letter/evolutionary-biologics-inc/73576c4d-c03e-429c-9793-a3b8e733f8e5

> FDA WARNING_LETTER for Evolutionary Biologics Inc. on January 28, 2025. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Evolutionary Biologics Inc.
- Inspection Date: 2025-01-28
- Product Type: Biologics
- Office Name: Center for Biologics Evaluation and Research
- Summary: The FDA issued a Warning Letter to Evolutionary Biologics on December 30, 2024, citing the sale of unapproved new drugs and unlicensed biological products: EXO RNA™, EVO JEL™, and EVO HYBRID™. The FDA reviewed the company's website, www.evolutionarybiologics.com/rx, and determined these products are intended for disease treatment or to affect body structure/function, making them drugs and biological products.

EVO JEL™ (umbilical cord-derived) and EVO HYBRID™ (umbilical cord, "placental tissue," and amniotic membrane-derived) are also Human Cells, Tissues, or Cellular or Tissue-Based Products (HCT/Ps). They fail to meet the criteria for regulation solely under section 361 of the PHS Act and 21 CFR Part 1271. Specifically, EVO JEL™ and EVO HYBRID™ are not for homologous use (e.g., treating inflammation, joint tears, or regenerating tissue is not homologous to umbilical cord/amniotic membrane function). They also fail the minimal manipulation criterion, as processing into a "flowable" form alters their original structural characteristics.

EXO RNA™ (exosome product) is also deemed an unapproved new drug and unlicensed biological product. The FDA noted a public safety notification regarding exosome products due to serious adverse events.

The company lacks approved biologics license applications (BL

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/evolutionary-biologics-inc/baeeea41-925d-4d06-babb-8fa7b9c2e2af

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