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# New Life Medical Selling Unapproved HCT/Ps
- URL: https://www.fdaweb.com/new-life-medical-selling-unapproved-hct-ps/
- Published: 2025-10-08T12:00:00.000Z
- Updated: 2026-09-14T15:23:44.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5160004

A 5/14-5/20/2024 FDA inspection at New Life Medical Services in Lutz, FL, found that the company sells human products derived from umbilical cord, amniotic fluid, and exosomes for allogeneic use. A 9/24 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-life-medical-services-llc-711102-09242025?ref=fdaweb.com) says the firm’s products are legally considered to be unapproved new drugs and unlicensed biological products. Introducing such products into interstate commerce is prohibited under the law, the letter says.

New Life’s products are human cells, tissues, or cellular or tissue-based products, FDA says, and legally must be covered by an approved BLA, which the company does not have.

FDA says New Life should respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of the actions and a schedule for completing the corrections.