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FDA establishment 3010888655, Oceanside, California, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 2
Official action indicated: 1
Last inspection ended: Sep 4, 2025
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 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.
21 CFR 211.68(b). Computer control of master formula records Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
21 CFR 211.160(a). Lab controls established, including changes The establishment of laboratory control mechanisms including any changes thereto, are not reviewed and approved by the quality control unit.
21 CFR 211.165(e). Test methods The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy and 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 820.20(b). Lack of or inadequate organizational structure The organizational structure has not been established and maintained to ensure that devices are in accordance with 21 CFR 820.
21 CFR 211.188(b)(7). Documentation of Actual Yield and Theoretical Yield The batch production and control records are deficient in that they do not include a statement of the actual yield.
21 CFR 211.142. Written warehousing procedures established/followed Procedures describing the warehousing of drug products are not followed.
21 CFR 211.160(b)(2). Acceptance of in-process materials Determinations of conformance to appropriate written specifications for acceptance are deficient for in-process materials.
21 CFR 211.194(a). Complete test data included in records Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
21 CFR 820.100(b). Documentation Corrective and preventive action activities and/or results have not been adequately documented.
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. 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 and warning letters
Oceanside, California, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.