US FDA Regulatory reporting and change control findings

Written procedures have not been developed for the reporting to FDA of post marketing adverse drug experiences.

An annual report was not submitted within 60 days of the anniversary date of U.S.

An MDR report was not submitted within 30 days ofreceiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Your outsourcing facility compounds drug products using bulk drug substances that cannot be used in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they (a) are not used to compound drug products that appear on the drug shortage list in effect under section 506E of the Act and (b) do not appear on a list developed by FDA of bulk drug substances for which there is a clinical need.

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 [email protected].

Your outsourcing facility has not submitted a report to FDA identifying a product compounded during the previous six months as required by section 503B(b)(2)(A) ofthe Federal Food, Drug, and Cosmetic Act (FD&C Act).