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 3013075152, Malden, Massachusetts, 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 13, 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 812.150(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.
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