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FDA establishment 3013897343, Boca Raton, Florida, United States. Part of E5 Pharma'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: Feb 17, 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 314.80(b). Failure to develop written procedures Written procedures have not been developed for the surveillance, receipt, evaluation and reporting to FDA of post marketing adverse drug experiences.
21 CFR 314.80(c)(2)(ii)(A). Incomplete periodic safety report You failed to submit a periodic report containing a narrative summary and analysis of the ADE information for the reporting interval in the report and a history of actions taken since the last report because of adverse drug experiences.
21 CFR 310.305(c). Failure to submit ADE report Adverse drug experience information has not been reported to FDA.
21 CFR 310.305(a). Failure to develop written procedures Written procedures have not been developed for the surveillance, receipt, evaluation and reporting to FDA of postmarketing adverse drug experiences.
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. Part of