CRITICALStem Cell / RegenerativeFDA Warning Letter · September 12, 2025

Cellebration LLC

Atlas ID: 2025-09-fda-cellebration-llc-11cm9i

FDA issued a warning letter to Cellebration LLC (San Juan, Puerto Rico) after the company failed to provide records requested under section 704(a)(4) of the FD&C Act regarding its cord blood-derived cellular products marketed for treating conditions including autism, cerebral palsy, multiple sclerosis, and Parkinson's disease. The company repeatedly delayed and ultimately never submitted the requested records despite multiple extensions and follow-up communications spanning October 2024 through May 2025. FDA determined the products constitute unapproved drugs and biological products under the FD&C Act and PHS Act, and that the refusal to provide records violates section 301(e) of the FD&C Act. FDA warned that failure to adequately address the matter may result in seizure and/or injunction without further notice.

Flagged claims (1)

cellular products derived from cord blood for use in the treatment or prevention of various diseases or conditions, such as autism, cerebral palsy, chronic pain, colitis, Crohn's disease, degenerative disease, gout, liver cirrhosis, multiple sclerosis, neurological disorders, Parkinson's disease, spine and disc conditions, sports injuries, and arthritis

Unsubstantiated efficacy · unapproved-biologic-disease-treatment-claims

Required actions (3)

We request that you respond in writing within fifteen (15) working days from your receipt of this letter. If you cannot address this matter within fifteen (15) working days, please explain the reason for your delay and the timeframe for completion.

Response required · 15 days

In response to this letter, we again ask you to provide the information and records requested by FDA pertaining to Cellebration, located at (b)(6) San Juan, PR, 00909, and your cellular products derived from cord blood.

Other

Failure to adequately address this matter may result in legal action being initiated by FDA without further notice, including, without limitation, seizure and/or injunction.

Injunction

Source

www.fda.gov · FDA Warning Letter

Does your site contain similar claims?

The free site audit scans your whole site against every entry in this Atlas. Most stem cell / regenerative sites match 3-6 patterns.

Run my free site audit

Worried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.

Check specific copy in the Claim Checker