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FDA establishment 3008798439, Ft Lauderdale, Florida, United States. Part of ECI Pharmaceuticals's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 5
Official action indicated: 0
Last inspection ended: Jan 27, 2023
Warning letters: 2
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(j). Failure to maintain records You failed to maintain for a period of 10 years records of all adverse drug experiences known to you, including raw data and any correspondence.
21 CFR 314.81(b)(2). Timely submission An annual report was not submitted each year to the FDA division responsible for reviewing the application.
21 CFR 314.80(c)(2). Late submission of annual safety reports Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application.
21 CFR 314.80(b). Failure to develop written procedures Written procedures have not been developed for the surveillance, evaluation and reporting to FDA of post marketing adverse drug experiences.
Voluntary Action Indicated (VAI)
Apr 22, 2022
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Feb 22, 2019
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Nov 18, 2016
Drugs · Unapproved and Misbranded DrugsDrugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Feb 27, 2015
Drugs · Unapproved and Misbranded DrugsDrugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Warning Letters
Letters naming this establishment; each opens the letter
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
Ft Lauderdale, Florida, United States. Part of