NexCell Scientific Inc — FDA Warning Letter Findings

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.

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.

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.

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.

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.

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) .

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.