ECI Pharmaceuticals LLC
Form 483 issued January 27, 2023 · Ft. Lauderdale, Florida
- Inspection
- Jan 23 – Jan 27, 2023
- Observations
- 3
- Pages
- 6
- FEI number
- 3008798439
In short: On January 27, 2023, FDA issued a Form 483 with 3 observations to ECI Pharmaceuticals LLC in Ft. Lauderdale, Florida (FEI 3008798439) after an inspection that ran Jan 23 – Jan 27, 2023. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences).
What FDA observed
Preview: the opening words of each observation- 01
Written procedures have not been developed for the surveillance, evaluation and reporting to FDA of post…
- 02
An annual report was not submitted each year to the FDA division responsible…
- 03
Not all annual periodic adverse drug experience reports have been submitted within days of the anniversary…
This inspection in context
Questions about this 483
What did FDA find at ECI Pharmaceuticals LLC?
FDA listed 3 observations on this Form 483. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences). The opening words of each observation are shown on this page.
When was ECI Pharmaceuticals LLC inspected by FDA?
The inspection ran Jan 23 – Jan 27, 2023, and the Form 483 is dated January 27, 2023.
How do I get the full Form 483 for ECI Pharmaceuticals LLC?
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