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FDA establishment 3015826052, Irvine, California, United States. Part of NexCell Scientific's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 1
Official action indicated: 1
Last inspection ended: Feb 5, 2026
Warning letters: 1
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
Biologics · Human Cellular, Tissue, and Gene Therapies
18 cited references
21 CFR 211.188. Prepared for each batch, include complete information Batch production and control records do not include complete information relating to the production and control of each batch.
21 CFR 211.198(a). Procedures to be written and followed Procedures describing the handling of all written and oral complaints regarding a drug product are not established, written and followed.
21 CFR 211.22(a). Lack of quality control unit There is no quality control unit.
21 CFR 211.194(c). Testing and standardization of standards et. al. Laboratory records do not include complete records of any testing and standardization of laboratory reference standards, reagents and standard solutions.
21 CFR 211.67(b). Written procedures not established/followed Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
21 CFR 211.150(b). Recall facilitation A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary, has not been established.
21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
21 CFR 211.42(c)(10)(v). Cleaning System Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
21 CFR 211.28(b). Habits of good sanitation & health Production personnel were not practicing good sanitation and health habits.
21 CFR 211.80(a). Procedures To Be in Writing Written procedures are lacking which describe in sufficient detail the receipt, identification, storage, handling, sampling, testing, approval and rejection of components, drug product containers and closures.
21 CFR 1271.50(a). Responsible person to determine, document The eligibility of an HCT/P donor was not determined and documented by a responsible person, based on results of donor screening and donor testing.
21 CFR 1271.75(a)(1). Risk factors, clinical evidence Donors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
21 CFR 1271.85(b)(2). SOP for release; reactive for CMV A standard operating procedure for the release of HCT/Ps from donors that test reactive for cytomegalovirus (CMV) was not established, maintained, defined, documented, implemented and followed.
21 CFR 1271.47(a). Design of procedures to ensure compliance Procedures were not designed to ensure compliance with the donor eligibility requirements.
21 CFR 1271.55(a)(3). Summary--records used to make determination After completion of the donor-eligibility determination, HCT/Ps were not accompanied with the summary of the records used to make the donor-eligibility determination.
21 CFR 211.125(a). Strict control not exercised over labeling issued Strict control is not exercised over labeling issued for use in drug product labeling operations.
Official Action Indicated (OAI)
Warning Letters
Letters naming this establishment; each opens the letter
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard, warning letters and enforcement reports
Irvine, California, United States. Part of