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 7.4.3. Purchased product verification activities not established or implemented The inspection or other activities necessary for ensuring that purchased product meets specified purchasing requirements were not adequately established and implemented.
21 CFR 803.17(b)(1). Info evaluated to determine if event was reportable The written MDR procedure does not include documentation and recordkeeping requirements for all information that was evaluated to determine if an event was reportable.
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
Miami, Florida, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.