Drug establishmentActive, Registered FY2026FDA warning letter on file

ECI Pharmaceuticals LLC

ECI Pharmaceuticals LLC is an FDA-registered drug establishment (FEI 3008798439) located in Ft. Lauderdale, Florida. The facility is active, registered for FY2026. Its most recent FDA inspection on record (2023-01-27) was classified VAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Feb 3, 2022

Failure to Register and List

Read the letter on FDA.gov ›

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

Establishment record

FEI Number

3008798439

Address

5311 NW 35th Terrace, Ft. Lauderdale, Florida

Establishment type

Drug establishment

Products / operations

Analytical testing, Labeling, Manufacturing, Packaging, Repackaging

Registration status

Active, Registered FY2026

Verify this record on FDA.gov ›

Inspection history

Inspections on file

Jan 27, 2023 · Voluntary Action Indicated (VAI)
Apr 22, 2022 · No Action Indicated (NAI)
Feb 22, 2019 · No Action Indicated (NAI)
Nov 18, 2016 · Voluntary Action Indicated (VAI)
Nov 18, 2016 · Voluntary Action Indicated (VAI)
Feb 27, 2015 · Voluntary Action Indicated (VAI)
Feb 27, 2015 · Voluntary Action Indicated (VAI)

Form 483 observations

Jan 27, 2023, 4 observations: Timely submission; Late submission of annual safety reports; Failure to maintain records

Questions

Is ECI Pharmaceuticals LLC registered with the FDA?

Yes. ECI Pharmaceuticals LLC is an FDA-registered drug establishment (FEI 3008798439) in Ft. Lauderdale, Florida. Its current registration status is Active, Registered FY2026.

Has ECI Pharmaceuticals LLC received an FDA warning letter?

Yes. FDA issued a warning letter to ECI Pharmaceuticals LLC; the most recent is dated Feb 3, 2022 (Failure to Register and List).

What does ECI Pharmaceuticals LLC do?

ECI Pharmaceuticals LLC's FDA-registered operations are: Analytical testing, Labeling, Manufacturing, Packaging, Repackaging.

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Source: FDA public data · status as of 2026-06-06