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Cellebration LLC, a biologics company based in Puerto Rico, was warned for marketing cord blood-derived cellular products for treating serious conditions including autism, cerebral palsy, Parkinson's disease, and multiple sclerosis without FDA approval, thereby violating the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA's Section 704(a)(4) record inspection requirements, initially refusing to provide requested records and information despite receiving two deadline extensions (approved in November 2024 and January 2025) to work with legal counsel and gather necessary documentation. This non-compliance with the information request constituted a prohibited act under Section 301(e) of the FD&C Act.