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RenatiLabs Inc. was warned for manufacturing and distributing WJMAX™, a human umbilical cord-derived product intended for therapeutic use via injection or topical application, which the FDA classified as a drug and biological product requiring premarket review. The company failed to comply with 21 CFR Part 1271 regulations for human cells, tissues, and cellular products (HCT/Ps), specifically because the product did not meet the homologous use criterion in 21 CFR 1271.10(a)(2) and did not qualify for any applicable exceptions. RenatiLabs distributed the product directly to physicians throughout the United States without proper FDA authorization, making it subject to additional regulatory requirements beyond the basic HCT/P framework.