Signature Biologics, LLC
FDA issued a warning letter to Signature Biologics, LLC (Irving, TX) regarding its Signature Cord™ product, derived from human umbilical cord tissue and distributed to healthcare professionals for allogeneic injection use. The agency found the product constitutes an unapproved biological drug requiring a valid Biologics License Application (BLA) or active IND, neither of which was in place, and that it fails the minimal manipulation and homologous use criteria under 21 CFR 1271.10(a). FDA also documented seven significant CGMP deviations including inadequate aseptic process validation, insufficient environmental monitoring, missing endotoxin testing, unvalidated manufacturing processes, and unsupported expiration dating. Failure to adequately respond may result in seizure and/or injunction.
Flagged claims (3)
your product is intended to treat diseases or conditions
Your product is intended for injection and purported to be sterile.
Signature Cord™ appears to be intended to treat orthopedic diseases and conditions
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.
your responses do not address your specific plans for disposition of the inventory of Signature Cord™ at your facility.
Failure to adequately address these matters may lead to regulatory action without further notice. Such actions include seizure and/or injunction.
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