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WARNING LETTER

September 12, 2025

CBER 25-713252

Dear Mr. Kaltner:

The United States Food and Drug Administration (FDA) reviewed your company’s website, https://www.cellebration.com/conditions (last visited September 2025), through which your company offers 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. As a result, your products are drugs as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i).

It is a prohibited act under section 301(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 331(e), to refuse to permit access to or copying of any record as required by section 704(a) of the FD&C Act, 21 U.S.C. § 374(a).

Under section 704(a)(4) of the FD&C Act, 21 U.S.C. § 374(a)(4), you are required to provide within a reasonable timeframe, within reasonable limits, and in a reasonable manner, requested records or information that FDA may inspect under section 704. However, your firm failed to comply with this requirement.

Specifically, on October 18, 2024, FDA sent an electronic request for records and other information pursuant to section 704(a)(4) of the FD&C Act to the above address. On November 5, 2024, you requested a 30-day extension to the submission deadline. You noted the additional time would allow your firm to “work closely with legal counsel to meet all standards and respond comprehensively.” On November 13, 2024, FDA approved your extension request. On January 3, 2025, your firm requested a second 30-day extension due to the holidays and an unexpected illness. FDA approved this request on January 10, 2025. As you failed to answer our initial request for records, we sent a second request via e-mail on April 23, 2025. You indicated on April 28, 2025, that you had sent your response weeks earlier; however, our records reflect that no such response was received. On May 19, 2025, FDA requested that you resend the response referenced in your email. In response, you stated that you were unclear about what we were seeking. On May 21 and May 28, 2025, we sent additional follow-up emails again asking you to provide the requested records.

FDA has not received a response to its request to date even though FDA’s request and follow-up communications sufficiently and clearly described the records sought. Your refusal to permit access to or copying of any record required by section 704(a), 21 U.S.C. § 374(a), violates section 301(e) of the FD&C Act, 21 U.S.C. § 331(e).

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.

Your firm should take prompt action to address this matter. This letter notifies you of our concerns and provides you an opportunity to address them. 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.

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. If you do not believe your products are in violation of the FD&C Act, PHS Act, or applicable regulations, include your reasoning and any supporting information for our consideration.

Send your electronic response and any questions regarding this letter to CBERDCMRecommendations@fda.hhs.gov.

Sincerely,
/S/

Melissa J. Mendoza
Director
Office of Compliance and Biologics Quality  
Center for Biologics Evaluation and Research

Cc: 

George Kaltner
Cellebration Regeneration Limited Liability Company
15 Ave. Munoz Rivera, Suite 103
Paseo Caribe, San Juan, PR 00901