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.
FDA establishment 3016547665, Boca Raton, Florida, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 1
Official action indicated: 0
Last inspection ended: Jan 26, 2021
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 812.46(b)(1). No evaluation of unanticipated adverse effects An evaluation of reported unanticipated adverse device effects was not conducted.
21 CFR 812.140(a)(2)(i). Investigator device accountability inadequate Records of receipt, use and disposal of a device that relate to the batch number or code mark of the device are not all complete.
21 CFR 812.40. Sponsors' general responsibilities For an investigational study, proper monitoring was not ensured.
21 CFR 812.150(b)(5). Sponsor progress reports for significant risk study Progress reports for a significant risk device study were not submitted at least yearly to FDA and all reviewing IRBs.
21 CFR 812.150(b)(1). Sponsor evaluation rpt not timely, distributed Reports of the results of evaluation of unanticipated adverse device effects were not all submitted to FDA and all reviewing IRBs.
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
Boca Raton, Florida, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.