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 3030828803, Hackensack, New Jersey, 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: Mar 17, 2025
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 812.140(d). Record retention inadequate Required records were not all maintained during the investigation.
21 CFR 812.150(a)(1). Investigator report of unanticipated adverse effects A complete and accurate report of an unanticipated adverse device effect was not prepared and submitted to the sponsor.
21 CFR 812.140(a)(3). Investigator's subject records inadequate Records of each subject's case history are not all accurate and complete.
21 CFR 812.110(b). Investigator non-compliance with agreement/plan/regulations An investigation was not conducted in accordance with the investigational plan.
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
Hackensack, New Jersey, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.