> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Platinum Biologics Selling Unapproved New Drugs: FDA
- URL: https://www.fdaweb.com/platinum-biologics-selling-unapproved-new-drugs-fda/
- Published: 2025-08-28T12:00:00.000Z
- Updated: 2026-09-14T15:20:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159774

An FDA review of a Web site maintained by Platinum Biologics of Orlando, FL, determined that the company sells two umbilical cord-derived products and two exosome products, all for allogenic use. An 8/15 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/platinum-biologics-llc-705090-08152025?ref=fdaweb.com) says the four products are unapproved new drugs and unlicensed biological products.

The letter says that based on information and records reviewed by the agency, the products are intended to treat autoimmune disease, pain, depression, and the repair of age-related and trauma-related defects in connective tissue, leading to their regulation as drugs.

The four products are subject to premarket review and approval requirements, FDA says, and are not the subject of an approved BLA.

Platinum was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation showing that the matters have been addressed and a schedule for completing the corrections.