Hallandale Pharmacy: what the records show

What the 2020 warning letter covered

Warning letter 605569, dated March 11, 2020, followed an inspection from July 2 to July 13, 2018. That inspection took place at Hallandale's former site at 1109 East Hallandale Beach Boulevard, and the FDA issued a Form 483 on July 13, 2018. The letter was addressed to owner and CEO David Rabbani at the current Fort Lauderdale address.

• Products named: a benzocaine/lidocaine/tetracaine cream and a 5 mL vial of Tri-Mix (an injectable erectile-dysfunction mixture). The letter does not mention semaglutide or tirzepatide.
• 503A conditions: the FDA said some products were made without valid prescriptions for individually identified patients. That made them ineligible for the 503A exemptions.
• Insanitary conditions: power to the sterile suite was shut off during cleaning; there were holes in walls, rust and debris; smoke studies were not done under dynamic conditions; and media fills did not simulate the most challenging conditions.
• CGMP citations: 21 CFR 211.42(c), for lacking separate or defined areas to prevent contamination, and 21 CFR 211.113(b), for inadequate written procedures to prevent microbial contamination of sterile drugs.

The FDA recommended a full review of operations with a third-party sterile-manufacturing consultant. It closed out the letter on May 3, 2022.

Do the 2025 findings repeat the 2018 ones?

In part, yes. Both inspections recorded problems with the airflow tests used to show that sterile work areas stay clean while staff are working in them.

The FDA's 2025 pharmacy inspections page lists the June 13, 2025 Form 483. A Form 483 records an investigator's observations. It is not a final agency decision. The FDA sends an FMD-145 letter with the inspection report once it considers an inspection closed. We found no warning letter after the 2025 inspection as of October 14, 2026.

Does Hallandale fill tirzepatide for telehealth programs?

Hallandale's public catalog listed semaglutide vials, and we did not see tirzepatide on it. Several telehealth programs still name Hallandale for GLP-1 orders:

• IVIM Health lists Hallandale among six possible dispensing pharmacies and says the "pharmacy may change with each order" (read October 14, 2026).
• Lavender Sky Health prices compounded tirzepatide by pharmacy. On October 14, 2026 its Hallandale tiers ran from $249 (Tier 1, 40 mg total) to $349 (Tier 4, 120 mg total), paid once, up front.
• NexLife's microdose pages listed Hallandale among five pharmacies when we read them on September 17, 2026. NexLife's standard tirzepatide plan page names Absolute, Premium Compounding and Boudreaux's instead.

If a program can route your order to Hallandale, read the pharmacy name and the drug concentration on each new vial label. Concentration determines how many syringe units equal your dose. Compounded tirzepatide is not FDA-approved. Compare IVIM and Lavender Sky.

What is ISO 5 air, and why did the 2025 inspection flag it?

ISO 5 is a cleanroom air-quality class. It allows no more than 3,520 particles of 0.5 micrometers or larger per cubic meter of air. Under USP chapter <797>, sterile injectables such as compounded GLP-1 vials must be prepared inside an ISO 5 work area, usually a laminar-airflow hood or isolator. The surrounding rooms may have dirtier air. When materials are "exposed to lower than ISO 5 quality air," as the 2025 Form 483 recorded, particles or microbes can reach an open vial or syringe.

Smoke studies are how a pharmacy shows that air in the ISO 5 zone flows away from the product while staff are working, not just when the hood is empty. Both the 2018 inspection and the 2025 inspection found these studies inadequate under working conditions. The 2025 observations concerned testosterone and NAD+ preparations, not GLP-1s.