Atlas

FDA-Inspected Site

ECI Pharmaceuticals LLC

6 FDA inspections are on record for ECI Pharmaceuticals LLC in Ft Lauderdale, United States.

483· Form 483 issued

Ft Lauderdale, United States · Last updated July 9, 2026

Overview

  • 6 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2023-01-27.

At a glance

Inspections

6

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
23 Jan 2023 – 27 Jan 2023Human Drugs483View 483 →
18 Apr 2022 – 22 Apr 2022Human DrugsClean
19 Feb 2019 – 22 Feb 2019Human DrugsClean
31 Jul 2017 – 8 Aug 2017Human DrugsClean
7 Nov 2016 – 18 Nov 2016Human Drugs483View 483 →
23 Feb 2015 – 27 Feb 2015Human Drugs483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

27 Jan 2023
21 CFR 314.80(b)

Failure to develop written procedures

Cited by Matthew F Duff

27 Jan 2023
21 CFR 314.80(c)(2)

Late submission of annual safety reports

Cited by Matthew F Duff

27 Jan 2023
21 CFR 314.80(j)

Failure to maintain records

Cited by Matthew F Duff

27 Jan 2023
21 CFR 314.81(b)(2)

Timely submission

Cited by Matthew F Duff

18 Nov 2016
21 CFR 211.110(a)(3)

Mixing adequacy

Cited by Jennifer Lalama, Ileana Barreto-Pettit

Investigators

FDA investigators tied to this site in the record.

Jennifer L Huntington2 insp.
Ileana Barreto-Pettit2 insp.
Matthew F Duff1 insp.
Shelby N Turner1 insp.
Alan A Rivera1 insp.
Jennifer Lalama1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.160(a)Cited across public-safe Form 483 observations5x
21 CFR 211.110(a)(3)Cited across public-safe Form 483 observations4x
21 CFR 211.42(c)Cited across public-safe Form 483 observations4x
21 CFR 211.46(b)Cited across public-safe Form 483 observations4x
21 CFR 211.63Cited across public-safe Form 483 observations4x
21 CFR 211.67(b)Cited across public-safe Form 483 observations4x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(8)Cited across public-safe Form 483 observations1x
21 CFR 211.84(b)Cited across public-safe Form 483 observations1x
21 CFR 314.80(b)Cited across public-safe Form 483 observations1x
21 CFR 314.80(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 314.80(j)Cited across public-safe Form 483 observations1x
21 CFR 314.81(b)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind ECI Pharmaceuticals LLC's 3 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat