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 820.25(b). Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been adequately established.
21 CFR 820.70(i). Software validation for automated processes Software used as part of the quality system has not been adequately validated for its intended use according to an established protocol.
21 CFR 820.198(c). Investigation of device failures Complaints involving the possible failure of a device to meet any of its specifications were not investigated where necessary.
7382.850, Inspection of Medical Device Manufacturers
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
Denton, Texas, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.