Row1 Inc. dba Regenative Labs
FDA issued a warning letter to Row1 Inc. dba Regenative Labs (Pensacola, FL) regarding its umbilical cord-derived cellular products (ProText™, CoreText™, CryoText™ Pro, CryoText™ Plus, SecreText™, and SecreText™ Pro), finding they constitute unapproved biological drugs requiring a Biologics License Application (BLA) or active IND, neither of which the company holds. The products failed to meet the homologous-use and minimal-manipulation criteria under 21 CFR 1271.10(a), meaning they cannot be regulated solely as HCT/Ps under section 361 of the PHS Act. FDA also documented significant CGMP deviations including unvalidated aseptic processes, inadequate environmental monitoring, improper personnel practices, and unsupported five-year expiration dating. The letter warns that failure to adequately respond may result in seizure and/or injunction.
Flagged claims (3)
your products are intended for clinical use in humans to treat a variety of diseases or conditions
Using your products to treat orthopedic diseases or conditions, for example, is not homologous use as defined in 21 CFR 1271.3(c).
you assign a five-year expiration date to your products without supporting data regarding the stability characteristics of the products
Required actions (3)
We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence.
Failure to adequately address these matters may lead to regulatory action without further notice. Such actions include seizure and/or injunction.
Your response also does not adequately address your failure to have an IND in effect to study your products addressed in this letter or your lack of an approved BLA to lawfully market your products.
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