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 3023527320, Irvine, California, United States. Part of LimFlow's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 1
Official action indicated: 0
Last inspection ended: May 15, 2023
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 812.40. Sponsors' general responsibilities For an investigational study, proper monitoring was not ensured and FDA was not promptly informed of significant new information about an investigation.
21 CFR 812.46(a). Sponsor securing investigator compliance An investigator was not complying with the investigational plan and compliance of the investigator was not promptly secured.
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
Irvine, California, United States. Part of