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.
ISO 13485:2016 Clause 7.1. Product realization risk management processes not documented One or more processes for risk management in product realization have not been adequately documented.
21 CFR 830.310(b). GUDID Information required for unique device identification. The correct unique device identifier (UDI) information regarding device identifier portion of the UDI assigned to the version or model, the device identifier that was previously assigned to the version or model and the FDA premarket submission number of a cleared or approved device was not provided to the FDA via the Global Unique Device Identification Database (GUDID).
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
Warwick, United Kingdom. Every inspection FDA has posted for the site, with its outcome and cited regulations.