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# Stratus Illegally Marketing Biologics: FDA
- URL: https://www.fdaweb.com/stratus-illegally-marketing-biologics-fda/
- Published: 2023-07-25T12:00:00.000Z
- Updated: 2026-09-14T18:46:16.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5154941

A 10/2/21-11/10/21 inspection at Stratus Biosystems, doing business as CellGenuity Regenerative Science in Grapevine, TX, documented that the firm manufactures products for allogeneic use, including an umbilical cord and amniotic membrane-derived product and an amniotic fluid-derived product. A 6/5 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stratus-biosystems-llc-dba-cellgenuity-regenerative-science-631303-06052023?ref=fdaweb.com) says the products are regulated as drugs, biological products, and human cell, tissue, or cellular or tissue-based products (HCT/Ps) and are being marketed illegally by Stratus because it does not have an approved IND or BLA for them.

The letter says the FDA investigators also found evidence of significant deviations from current good manufacturing practice (CGMP) requirements. Specific violations were:

- failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of all aseptic and sterilization processes;
- failing to have an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
- failing 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;
- failing to establish 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;
- failing to thoroughly investigate any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed; and
- failing to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use the results of such stability testing to determine appropriate storage conditions and expiration dates.

Stratus was told to respond with a list of specific steps it has taken or plans to take to address any violations and prevent their recurrence, with documentation necessary to show that the matters have been addressed, and a schedule for completing the corrections.