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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.