Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
21 CFR 211.130(c). Lot or control number assigned The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing.
21 CFR 211.137(d). Expiration date location on labeling Drug product expiration dates do not appear on the labeling in the manner prescribed by regulations.
21 CFR 211.188. Prepared for each batch, include complete information Batch production and control records are not prepared for each batch of drug product produced.
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 identity and strength of each active ingredient prior to release.
21 CFR 211.166(a). Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products.
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
Aurora, Illinois, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.