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 820.70(b). Production and Process Change Procedures, lack of or Inad. Procedures for changes to a process and procedure have not been adequately established.
21 CFR 820.70(g)(3). Adjustment Inherent limitations or allowable tolerances are not posted on or near and are not readily available to personnel performing adjustments of equipment requiring periodic adjustments.
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