FacilityLedger

Device establishmentActive, RegisteredFDA warning letter on file

HEALTHTEX DISTRIBUTORS, INC.

HEALTHTEX DISTRIBUTORS, INC. is an FDA-registered device establishment (FEI 3000206696) located in Miami, Florida. The facility is active, registered. Its most recent FDA inspection on record (2023-12-01) was classified VAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Jun 15, 2023
CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
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
3000206696
Address
3555 NW 41 Street, Miami, Florida
Establishment type
Device establishment
Products / operations
Cardiovascular, Repack or Relabel Medical Device, General Hospital, General, Plastic Surgery
Registration status
Active, Registered

Verify this record in FDA source data ›

Inspection history

Inspections on file
Dec 1, 2023 · Voluntary Action Indicated (VAI)
Feb 1, 2023 · Official Action Indicated (OAI)
Sep 1, 2017 · Voluntary Action Indicated (VAI)
Apr 17, 2013 · No Action Indicated (NAI)
Apr 17, 2013 · Voluntary Action Indicated (VAI)
Form 483 observations
Dec 1, 2023, 3 observations: Written procedure quality control operations material review; Written procedures - holding; Personnel - quality control operations; responsibilities
Feb 1, 2023, 4 observations: Quality control - quality, dietary supplement; Records - returned dietary supplement: written procedures; Written procedures - holding; distributing
Sep 1, 2017, 6 observations: Written procedures - product complaint; review, investigate; Records - returned dietary supplement: written procedures; Specifications - identity, purity, strength, composition
Apr 17, 2013, 3 observations: Screening; Hand cleaning and sanitizing preparations; Suitable temp. and pressure

FDA record timeline

FDA inspection
VAI classification
Form 483
3 observations
Warning letter
CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Source ›
FDA inspection
OAI classification
Form 483
4 observations
FDA inspection
VAI classification
Form 483
6 observations
FDA inspection
NAI classification
FDA inspection
VAI classification
Form 483
3 observations

Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.

Questions

Is HEALTHTEX DISTRIBUTORS, INC. registered with the FDA?

Yes. HEALTHTEX DISTRIBUTORS, INC. is an FDA-registered device establishment (FEI 3000206696) in Miami, Florida. Its current registration status is Active, Registered.

Has HEALTHTEX DISTRIBUTORS, INC. received an FDA warning letter?

Yes. FDA issued a warning letter to HEALTHTEX DISTRIBUTORS, INC.; the most recent is dated Jun 15, 2023 (CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated).

What does HEALTHTEX DISTRIBUTORS, INC. do?

HEALTHTEX DISTRIBUTORS, INC.'s FDA-registered operations are: Cardiovascular, Repack or Relabel Medical Device, General Hospital, General, Plastic Surgery.

Related facilities

Chemco CorporationGADAL Laboratories, IncECI Pharmaceuticals LLCABR Laboratory LLCCellEra, LLCBECKMAN COULTER, INC.

Source: FDA public data · status as of 2026-08-22

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