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FDA establishment 3004758248, San Clemente, California, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.
Inspections: 3
Official action indicated: 1
Last inspection ended: Sep 27, 2024
Warning letters: 0
Import refusals since 2024: 8
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.
21 CFR 211.170(b). Drug product reserve containers Drug product reserve samples are not stored in the same immediate container-closure system as the marketed product and an immediate container-closure system that has essentially the same characteristics as the marketed product.
21 CFR 211.84(b). Representative Samples Criteria The number of containers to be sampled and amount of material taken from each container is not based upon appropriate criteria.
21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
21 CFR 211.110(b). In-process materials specifications In-process specifications are not derived from previous acceptable process average and process variability estimates where possible.
21 CFR 211.184(c). Individual inventory record Records fail to include an individual inventory record of each component and reconciliation of the use of each component with sufficient information to allow determination of any associated batch or lot of drug product.
21 CFR 211.67(b). Written procedures not established/followed Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
21 CFR 211.165(a). Testing and release for distribution Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
21 CFR 211.182. Personnel dating/signing equipment log The persons performing and double-checking the cleaning and maintenance are not dating and signing or initialing the equipment cleaning and use log.
Voluntary Action Indicated (VAI)
Jan 13, 2023
Drugs · Drug Quality Assurance
9 cited references
21 CFR 211.170(b). Annual visual exams of drug products Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
21 CFR 211.84(d)(2). Reports of Analysis (Components) Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design, of adequate size and suitably located to facilitate operations for its intended use.
21 CFR 211.166(a). Written program not followed The written stability testing program is not followed.
21 CFR 211.192. Quality control unit review of records Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
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 211.180(e)(2). Items to cover on annual reviews Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug product.
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 211.84(e). Rejecting When Specifications Not Met Failure to reject any lot of components that did not meet the appropriate written specifications for identity, strength, quality, and purity.
Official Action Indicated (OAI)
Oct 16, 2015
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Import Refusals
8 refused shipment lines since 2024, grouped by product and charges
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
San Clemente, California, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.