Hallandale Pharmacy FDA History: 483s, Warning Letter & What They Mean

Last verified: August 28, 2026

Quick answer

FDA's public compounding database shows a multi-year regulatory history for Pharmcore Inc. dba Hallandale Pharmacy, which FDA identifies as a 503A facility.

The record includes a March 2020 Warning Letter, a September 2021 amended Form 483, a May 2022 Warning Letter Close Out, a June 2025 Form FDA 483, and a November 2025 FMD-145 letter.

These documents do not all mean the same thing.

FDA states that a Form 483 contains inspection observations and does not represent a final agency determination regarding compliance. A warning letter is a separate, more formal enforcement communication. A warning-letter closeout indicates that FDA closed that particular warning-letter matter after evaluating corrective actions.

Hallandale FDA timeline

What was in the June 2025 Hallandale Form 483?

FDA inspected Hallandale from June 3 through June 13, 2025.

The resulting Form 483 contained two principal observations.

Observation 1: materials used in ISO-5 space

FDA investigators documented concerns about certain wipes that had been opened/stored in an ISO-7 area and were then used within ISO-5 hoods during sterile compounding.

Observation 2: smoke-study simulation

FDA also documented concerns about whether smoke studies adequately simulated routine processing under dynamic conditions and noted airflow observations during a reviewed study.

The important context appears on the form itself: the observations do not represent a final agency determination of compliance.

Was the 2025 Form 483 specifically about semaglutide or tirzepatide?

The form focused on sterile-compounding practices and process/environmental controls.

It did not make a public FDA finding that Hallandale semaglutide or tirzepatide was diluted, under-strength, or clinically ineffective.

That distinction matters because online discussions sometimes turn a facility-level inspection observation into a much more specific product claim than FDA actually made.

What did the 2020 warning letter mean?

A warning letter is a formal FDA communication describing cited violations and requesting corrective action.

Hallandale received one in March 2020.

But the current FDA database also lists a Warning Letter Close Out issued May 3, 2022.

A balanced summary should include both facts:

FDA issued the warning letter, and FDA later closed that warning-letter matter.

Does a Form 483 mean a pharmacy failed FDA approval?

No.

A 503A pharmacy is not "FDA approved" in the same way a finished drug is FDA approved.

A Form 483 is an inspection record. FDA evaluates the observations, the firm's response, corrective actions and other evidence before taking final regulatory action.

What is an FMD-145 letter?

FDA uses different forms of correspondence when coordinating oversight of compounding pharmacies, including communications involving state regulators.

An FMD-145 entry should not automatically be described as a warning letter. The document type matters.

This is why a timeline is more accurate than simply saying "Hallandale has FDA violations."

How should patients interpret older FDA records?

A sound approach is:

• preserve the historical record;
• date each document;
• distinguish 483s from warning letters;
• note when a warning letter was closed out;
• review current pharmacy quality disclosures;
• verify current licenses and accreditation.

Neither extreme is useful:

"The pharmacy has a 483, therefore everything it makes is unsafe."

or

"The old warning letter was closed, therefore regulatory history no longer matters."

Both oversimplify the evidence.

What does Hallandale currently say about quality?

Hallandale says its current operation includes:

• a 60,000-square-foot facility;
• controlled cleanrooms;
• environmental monitoring;
• analytical testing of sterile batches;
• stability studies;
• supplier qualification;
• PCAB accreditation;
• USP 797 sterile-compounding practices.

Those are the pharmacy's current disclosures. FDA records are independent regulatory documents. Both belong in a complete review.

How Ozari Health works with Hallandale Pharmacy

Ozari Health publicly identifies Hallandale Pharmacy as one of its two U.S.-licensed 503A compounding pharmacy partners, alongside VialsRx. Ozari says every prescription is patient-specific, written by a licensed prescriber, and routed according to the patient's state, medication and dose, and current pharmacy capacity.

Patients do not select the dispensing pharmacy by request. The prescription label identifies which pharmacy prepared the medication.

That disclosure creates an important distinction for patients researching GLP-1 telehealth companies: Ozari does not describe fulfillment only as coming from an unnamed "partner pharmacy." Patients can independently research Hallandale's facility, credentials, public FDA history, product catalog, and contact information.

Why Ozari names Hallandale publicly

Ozari's pharmacy-transparency approach lets patients independently evaluate the facility that may prepare their medication.

Patients can review:

• Hallandale's address;
• 503A status;
• accreditation;
• FDA history;
• product catalog;
• state coverage;
• contact information.

Transparency does not require pretending a pharmacy has no regulatory history. It requires presenting the history accurately and in context.

Frequently asked questions

Did Hallandale receive an FDA warning letter?

Yes, in March 2020.

Was the Hallandale warning letter closed?

FDA's current database lists a Warning Letter Close Out dated May 3, 2022.

Did Hallandale get a Form 483 in 2025?

Yes. FDA issued a Form 483 on June 13, 2025.

Is a Form 483 the same as a warning letter?

No.

Did FDA say Hallandale tirzepatide was diluted?

The June 2025 Form 483 does not make that finding.

Does Ozari still work with Hallandale?

Yes. Ozari's current Pharmacy Standards page lists Hallandale as one of its two 503A partners.

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Medical and regulatory disclaimer

This article is for informational purposes only and is not medical advice. Compounded medications are not FDA-approved finished drug products and are not reviewed by FDA for safety, effectiveness, or quality before marketing in the same way as FDA-approved drugs. A licensed clinician must determine whether a compounded medication is appropriate for an individual patient and whether the prescription meets applicable federal and state requirements.

Pharmacy availability, formulations, prices, state coverage, provider relationships, credentials, and regulatory records can change. Verify current information before making a treatment decision.

Sources

• FDA — Compounding inspections, recalls and other actions
• FDA — 2025 pharmacy inspections and related records
• FDA — Hallandale Form 483, June 13, 2025
• FDA — Compounding and the FDA: Questions and Answers
• Hallandale Pharmacy — Quality
• Ozari Health — Hallandale Pharmacy profile

Explore Ozari's pharmacy standards

Ozari Health publicly names the pharmacies that prepare eligible patient-specific compounded GLP-1 prescriptions.

• How Ozari sources medication
• Hallandale Pharmacy profile
• VialsRx Pharmacy profile
• Compounded semaglutide
• Compounded tirzepatide