Chara Biologics FDA Warning Letter | Stem Cell & Exosome Investigation

Federal regulators have issued multiple enforcement actions against Chara Biologics, Inc., a California company marketing amniotic fluid and umbilical cord-derived products. The most recent came on January 17, 2025, when the FDA’s Center for Biologics Evaluation and Research sent a formal warning letter after inspecting the firm’s Chatsworth facility.

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2025 FDA Warning Letter to Chara Biologics Indicates Unapproved Regenerative Products

The FDA letter identifies three products distributed for allogeneic use: CharaExo, described as a human amniotic fluid product containing extracellular vesicles; and CharaCore and CharaOmni, cellular products derived from human umbilical cord.

Agency reviewers found the company promoted these products for a wide range of conditions, including Parkinson’s disease, Alzheimer’s, multiple sclerosis, ALS, autism, diabetes, cardiovascular disease, spinal cord injuries, and cirrhosis. Brochures and physician materials claimed benefits such as reduced inflammation, tissue repair, and antimicrobial effects.

Because the products are intended to treat or prevent disease, the FDA classified them as unapproved new drugs under the Federal Food, Drug, and Cosmetic Act and unlicensed biological products under the Public Health Service Act.

Neither a biologics license application nor an investigational new drug application was in effect. CharaCore and CharaOmni also failed the minimal manipulation and homologous-use criteria that would have allowed lighter regulation as human cell and tissue products. As a result, they require full premarket approval.

Inspectors documented significant current good manufacturing practice and current good tissue practice violations. The firm lacked a functioning quality unit with authority to approve or reject products and labeling. Donor-eligibility determinations were incompletely documented.

Production and process controls were inadequate. In addition, CharaExo was found misbranded because the company extended expiration dates without supporting stability data.

Prior FDA Notice and Ongoing Manufacturing Concerns

This was not the company’s first notice from the agency. In November 2019, the FDA issued an untitled letter focused on website and social-media claims that CharaCore could help children with autism and patients with traumatic brain injury. The 2025 warning letter notes that earlier responses failed to resolve the core regulatory issues.

Across the regenerative medicine field, similar enforcement actions often arise when products are marketed for serious conditions without the clinical data required for approval.

Common consumer concerns in these cases include high costs for treatments that later show limited benefit, incomplete disclosure of regulatory status, and questions about manufacturing controls. These patterns appear in public records involving various firms and are not directed at any single company.

Patients who received amniotic or umbilical cord products and later learned of FDA findings may want to review the specific claims made to them, the cost of treatment, and any documented results or complications. Preserving receipts, consent forms, and marketing materials can help clarify next steps.

Anyone considering regenerative therapies should ask for clear documentation of FDA approval status and supporting clinical evidence before proceeding. The Chara Biologics letters form part of a broader pattern of agency attention to unapproved birth-tissue and exosome products.

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