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 812.140(a)(2)(iii). Investigator records of disposition of devices inadequate Records that relate to the reason why devices were returned to the sponsor are not all complete.
21 CFR 812.140(a)(2)(i). Investigator device accountability inadequate Records of use and disposal of a device that relate to the batch number or code mark of the device are not all accurate and complete.
21 CFR 812.140(a)(3)(iii). Investigator records of exposure to device inadequate Records of each subject's exposure to the device, including the date and time of each use are not all accurate and complete.
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
Bay City, Michigan, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.