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FDA establishment 3027372751, Saint Petersburg, Florida, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 2
Official action indicated: 0
Last inspection ended: Dec 20, 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 812.110(b). Investigator non-compliance with agreement/plan/regulations An investigation was not conducted in accordance with the signed agreement and the investigational plan.
21 CFR 812.110(d). Inadequate financial disclosure by investigator The sponsor was not supplied sufficient financial information to allow submission of complete and accurate certification or disclosure statements.
Voluntary Action Indicated (VAI)
Sep 27, 2023
Devices · Bioresearch Monitoring
1 cited reference
21 CFR 812.100. Investigator non-compliance with agreement/plan/regulations An investigation was not conducted according to the signed agreement and investigational plan.
7382.850, Inspection of Medical Device Manufacturers
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. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. 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, warning letters and enforcement reports
Saint Petersburg, Florida, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.