FDA WARNING_LETTER - Cellebration LLC

The FDA issued a Warning Letter to Cellebration LLC on September 12, 2025, identifying its cord blood-derived cellular products, marketed for various conditions like autism and arthritis, as unapproved drugs and biological products. The primary violation detailed in the letter stems from the company"s failure to provide access to, or copies of, legally required records. Over an extended period, from October 2024 through May 2025, the FDA"s Center for Biologics Evaluation and Research (CBER) made multiple requests for documentation. Despite granting two extensions and clarifying the information sought, Cellebration LLC repeatedly failed to submit the necessary records. This constitutes a violation of sections 301(e) and 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which mandate providing records for FDA review. Cellebration LLC is required to promptly furnish all previously requested information and records. The company must provide a written response within fifteen working days, detailing corrective actions or justifying its position. Failure to adequately address these concerns may lead to further legal actions, including product seizure or injunctions, without additional notice.