Signature Biologics, LLC

Warning LetterClosed

Neil H. Riordan, Ph.D. Chief Executive Officer Signature Biologics, LLC 4040 W. Royal Lane, Suite 100 Irving , TX 75063-2844 United States neil@aidanresearch.comFEI 3018035114Issued Sep 18, 2023Division of Biological Products Operations II

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3018035114.

Violations11

Issue DateSep 18, 2023

Product TypeBiologics

StatusClosed

Closeout LetterMar 6, 2025

Letter Details

Firm: Signature Biologics, LLC
Location: Neil H. Riordan, Ph.D. Chief Executive Officer Signature Biologics, LLC 4040 W. Royal Lane, Suite 100 Irving , TX 75063-2844 United States neil@aidanresearch.com
FEI Number: 3018035114
Country: United States
Issue Date: September 18, 2023
Issuing Office: Division of Biological Products Operations II
Product Type: Biologics
Status: Closed
Closeout Letter: March 06, 2025

Summary

Signature Biologics, LLC manufactured and distributed Signature Cord™, a human umbilical cord-derived product intended for injection to treat diseases, without proper regulatory authorization as a biological product and drug under FDA oversight. The company failed to qualify for any regulatory exception under 21 CFR 1271 for human cells, tissues, and cellular products (HCT/Ps), meaning the product required premarket review and approval that was not obtained before distribution to healthcare providers. The FDA determined during its December 2021 inspection that despite being marketed as a sterile allogeneic product, Signature Cord™ lacked the required regulatory compliance and appropriate drug/biological product classification necessary for lawful commercialization.

Signature Biologics, LLC FDA Warning Letter, September 18, 2023