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# BioStem Illegally Marketing Cellular Products: FDA
- URL: https://www.fdaweb.com/biostem-illegally-marketing-cellular-products-fda/
- Published: 2025-02-05T12:00:00.000Z
- Updated: 2026-09-14T14:52:32.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5158611

A 9/11-9/15/2023 FDA inspection at BioStem Life Sciences in Pompano Beach, FL, determined that the company manufactures cellular products derived from human umbilical cord and an amniotic membrane combined with amniotic fluid product. A 1/17 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/biostem-life-sciences-673788-01172025?ref=fdaweb.com) says that while such products are legally considered to be biologic drug products that require an approved BLA to be marketed legally, the company does not have an approved BLA.

The letter also lists these CGMP violations documented during the inspection:

- failure to establish an adequate system for monitoring environmental conditions in aseptic processing areas to prevent contamination;
- failure to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
- failure to establish adequate written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess;
- failure to establish laboratory controls that include scientifically sound and appropriate specifications designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity; and
- failure to establish and follow an adequate written testing program designed to assure the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates.

The letter says the firm’s multiple responses to the form FDA-483 it was issued are inadequate. The agency also raises a concern that the instructions for use of each of BioStem’s products says the allograft is processed aseptically but is not sterile. “FDA has serious safety concerns regarding their use on patients via injection,” the letter says. “FDA expects injectable products to be sterile, consistent with basic quality standards and to ensure patient safety.”

BioStem was told to 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.