WARNING LETTER

NexCell Scientific Inc MARCS-CMS 730612 — September 11, 2026

Delivery Method:: Via UPS and EMAIL
Reference #:: CBER 26-730612
Product:: Biologics

Recipient:: Recipient Name

Edwin Pinos; Recipient Title

President; NexCell Scientific Inc; 2 Hughes Ste 200
Irvine, CA 92618-2055
United States; ed@nexcellscientific.com

Issuing Office:: Center for Biologics Evaluation and Research; United States

WARNING LETTER

September 11, 2026

CBER 26-730612

Dear Edwin Pinos:

The United States Food and Drug Administration (FDA) inspected your facility, located at the above address, between December 9 and 12, 2025, and between February 3 and 5, 2026. During the inspection, FDA documented that your company manufactures an umbilical cord blood-derived total nucleated cell (TNC) product, in multiple concentrations, for allogeneic use (hereinafter, “your product”).

This letter is to advise you that your product is an unapproved new drug in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Your product is also an unlicensed biological product in violation of section 351(a)(1) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(a)(1). A biological product for which a biologics license application (BLA) has been approved under section 351(a) of the PHS Act is not required to have an approved application under section 505 of the FD&C Act, 21 U.S.C. § 355; 42 U.S.C. § 262(j). Otherwise, with certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act. Your introduction or delivery for introduction of your product into interstate commerce, or the causing thereof, is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. § 331(d).

This warning letter also summarizes significant violations of current good manufacturing practice (CGMP) requirements, including violations of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. § 351(a)(2)(B), and 21 CFR parts 210 and 211 in the manufacture of your product. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding drugs do not conform to CGMP, your product is adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. § 351(a)(2)(B). Your introduction or delivery for introduction of your product into interstate commerce, or the causing thereof, is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. § 331(a).

Unapproved New Drug and Unlicensed Biological Product Violations

Based on information and records reviewed by FDA, your product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and/or is intended to affect the structure or function of the body. For example:

Your website www.nexcelllabs.com includes the following statements in its “What is Regenerative Medicine?” page, along with assurances that your company “uses exclusively umbilical cord derived cells”:
o “Because of their ability to differentiate into cells that carry out the roles needed in a variety of organs, cell allografts are an essential regenerative tool. When these allografts are introduced into a damaged tissue or organ, they have the ability to evolve and carry out necessary functions, compensating for the damaged cells.”
o “When injected into a damaged tissue, the cells specialize to carry out the necessary function of that particular area, improving symptoms and function.”
o “[Mesenchymal stem cells] reduce the signal cells that promote inflammation… While this is another function that helps them avoid the immune response, it is also essential to the cells’ utility in chronic and autoimmune disease characterized by inflammation.”
o Under the heading “How Stem Cells Work”, “Once in the affected area, the cells … begin to produce signaling proteins that work to regulate inflammation, aid in angiogenesis, and promote tissue repair.”
The “Characterization of BioGenix® Allograft Products Independent Viability Study,” which you referenced during the FDA inspection as the “White Paper study” used to characterize your product, states:
o On page 4, under the heading “Applications and Advantages”: “Research suggests that the use of mesenchymal and hematopoietic stem cells may offer potential benefits for musculoskeletal issues, wound injuries, cirrhosis of the liver, blood disorders, cardiovascular conditions, neurological disorders, and systemic and autoimmune diseases. A number of clinical trials have specifically targeted autoimmune issues, including multiple sclerosis, psoriasis, Crohn's disease, rheumatoid arthritis, lupus erythematosus, and others.” (citations omitted).
o On page 10, under the heading “Discussion and Summation”: “Several research studies suggest that umbilical cord-derived allografts may have potential advantages for a range of indications, such as musculoskeletal disorders, modulation of immune responses, neurological conditions, liver cirrhosis, cardiovascular system issues, blood disorders, wound, and multiple variants of systemic or autoimmune disorders.” (citations omitted).

Therefore, your product is a drug as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and a biological product as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i).

Your product is also a human cell, tissue, or cellular or tissue-based product (HCT/P) as defined in 21 CFR 1271.3(d) and is subject to regulation under 21 CFR part 1271, issued under the authority of section 361 of the PHS Act, 42 U.S.C. § 264. HCT/Ps that do not meet all the criteria in 21 CFR 1271.10(a) are not regulated solely under section 361 of the PHS Act and the regulations in 21 CFR part 1271. Unless an exception in 21 CFR 1271.15 applies, such products are regulated as drugs, devices, and/or biological products under the FD&C Act and/or the PHS Act and are subject to additional regulation, including applicable premarket review. Based on a review of relevant materials, NexCell Scientific does not qualify for any exception in 21 CFR 1271.15, and your product fails to meet all criteria in 21 CFR 1271.10(a).

Your product fails to meet the criterion in 21 CFR 1271.10(a)(2) that the HCT/Ps be “intended for homologous use only.” Homologous use means that the “labeling, advertising, or other indications of the manufacturer’s objective intent” demonstrate that the HCT/P is intended to perform “the same basic function or functions in the recipient as in the donor” (21 CFR 1271.3(c) and 1271.10(a)(2)). Your umbilical cord blood-derived product is not intended solely to perform the same basic function or functions of the HCT/P in the recipient as in the donor (e.g., forming and replenishing the lymphohematopoietic system for umbilical cord blood). Rather, your product is intended for use in the treatment of various diseases and conditions, such as inflammation, injuries, neurological conditions and liver cirrhosis, which are not basic functions of umbilical cord blood in the donor.

In addition, your product fails to meet the criterion in 21 CFR 1271.10(a)(4) because it is manufactured from allogeneic umbilical cord blood, is dependent on the metabolic activity of living cells for their primary function, and is not for autologous use, allogeneic use in a first-degree or second-degree blood relative, or reproductive use.

Therefore, this HCT/P is not regulated solely under section 361 of the PHS Act, 42 U.S.C. § 264, and the regulations in 21 CFR part 1271.¹ See 21 CFR 1271.20. In addition to being regulated under section 361 of the PHS Act and 21 CFR part 1271, your product is regulated as a drug as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and a biological product as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i), as stated above.

Subject to certain exceptions not applicable here, to lawfully introduce or deliver for introduction into interstate commerce a drug that is a biological product, a valid BLA must be in effect under section 351(a)(1) of the PHS Act, 42 U.S.C. § 262(a)(1). Such licenses are issued only after showing that the product is safe, pure, and potent. Your product is not the subject of an approved BLA.

CGMP Violations

FDA’s inspection of your facility documented evidence of significant CGMP violations. At the conclusion of the inspection, the FDA investigators issued a Form FDA-483, List of Inspectional Observations (Form FDA-483). FDA also identified significant violations upon further review of the evidence collected during the inspection, as set forth below.

The CGMP violations applicable to your product include, but are not limited to, the following:

1. Failure to establish adequate written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess, as required by 21 CFR 211.100(a). For example, your firm has not validated the manufacturing process for your product with respect to identity, strength, quality, and purity.

2. Failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile including procedures for validation of all aseptic and sterilization processes, as required by 21 CFR 211.113(b). For example, your firm has not validated the aseptic process used to manufacture your product. Your product purports to be sterile and is expected to be sterile.

3. Failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity, as required by 21 CFR 211.160(b). For example, your firm has not established scientifically sound and appropriate specifications and test procedures to assure your product conforms to appropriate standards of identity, strength, quality, and purity. Your finished product testing is limited to sterility testing, visual inspection, and (b)(4).

4. Failure to thoroughly investigate any unexplained discrepancy, or the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed, as required by 21 CFR 211.192. For example, between August 2023 and June 2025, (b)(4) lots of your finished product failed sterility testing. While you discarded these lots, you did not conduct investigations to determine the root cause(s) and whether other lots were impacted.

5. Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions, as required by 21 CFR 211.42(c)(10)(v). For example, your firm has not validated
the cleaning and disinfection processes for your ISO (b)(4) cleanroom or ISO (b)(4) where your product is manufactured.

6. Aseptic processing areas are deficient regarding the system for environmental monitoring to prevent contamination, as required by 21 CFR 211.42(c)(10)(iv). For example, your firm has not established an adequate program for environmental and personnel monitoring in the aseptic processing area where your product is manufactured. At the time of the inspection, environmental and personnel monitoring was not performed in association with each production shift.

7. Failure to establish an adequate quality control unit that has the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated, as required by 21 CFR 211.22(a). For example, at the time of the inspection, your firm had one employee responsible for both manufacturing your product and quality unit responsibilities, with no independent quality unit in place.

Response to the Form FDA-483

We have reviewed your response, dated February 18, 2026, to FDA’s Form FDA-483 in detail. Your response is inadequate to address the violations noted above. For example, your response does not address your continued distribution of your product or specific plans for disposition of the remaining inventory manufactured under the violative conditions outlined above. Additionally, your corrective actions cannot be adequately evaluated because they lack supporting documentation.

Further, for previously distributed lots of your product, your response does not describe actions you have taken or plan to take that adequately address the impact of the above-noted deficiencies on lots that are still within expiry and were manufactured under the above-described violative conditions.

Your response also does not adequately address your failure to have an Investigational New Drug (IND) in effect to study your product addressed in this letter or your lack of an approved BLA to lawfully market your product. Your statement that you “are committed to achieving and maintaining compliance with 21 CFR Part 1271” does not resolve these issues, as your product does not meet the criteria to be regulated solely under section 361 of the PHS Act, as explained above. Your product is a drug and/or biological product, which is subject to premarket review and approval requirements.

Conclusion

Neither this letter nor the observations noted on Form FDA-483, which were discussed with you at the conclusion of the inspection, are intended to be an all-inclusive list of deficiencies that may exist in connection with your product. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure full compliance with all applicable requirements in the FD&C Act, PHS Act, and all applicable regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address these matters may result in action without further notice including, without limitation, seizure and/or injunction.

Please submit your response in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence. Include any documentation necessary to show that the matters have been addressed. If you cannot address these matters within fifteen (15) working days, please explain the reason for your delay and the timeframe for completion. If you do not believe your product is 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 CBER’s Office of Compliance and Biologics Quality, Division of Case Management at CBERDCMRecommendations@fda.hhs.gov.

Sincerely,
/S/

Vincent Amatrudo, JD
Acting Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research

Cc: Edwin Pinos, co-owner
(b)(4), (b)(6)

(b)(4), (b)(6)

___________________________

1 Because your product fails to meet at least one criterion in 21 CFR 1271.10(a), this letter does not evaluate all other criteria in 21 CFR 1271.10(a).