Key facts
| Firm | Pharmcore Inc. dba Hallandale Pharmacy |
|---|---|
| FEI / inspection ID | 3014480778 |
| Inspection end date | June 13, 2025 |
| Citation count | 2 |
Citations explained
Observation 1 — Materials were exposed to lower than ISO 5 quality air
Materials were exposed to lower than ISO 5 quality air. Specifically, Dming observation of sterile compounding activities on 6/3/2025 and 6/4/2025, it was observed that sterile.{ 15) {~ ) wipes, which were opened and stored in the ISO-7 cleamoom environment, were introduced and used within the ISO-5 hood dming sterile compounding processes. This practice potentially compromises the sterility of the ISO-5 environment and the products being compounded. For example: I.On 6/3/2025: a) Dming production of Testosterone Cypionate/Anastrozole (Grape Seed Oil) l0mL Vial 200Mg/0.5mg/mL (lot 421645): □ At approximately 11 :33 AM, a sterile compounding technician used an 4 (b) ( lwipe from the ISO-7 area to clean spilled diug product within the ISO-5 space. □ Empty opened vials were present in the ISO-5 area when the wipe was introduced. b) Dming production of Testosterone Cypionate/Propionate (Grape Seed Oil) 5mL Vial 180mg/20mg/mL (lot 421621): EMPLOYEE(S) SIGNATU RE DATE ISSUED SEE REVERSE Lo gan T Williams, I nves t iga t or.
Observation 2 — Smoke studies were inadequately per fo nned under dynamic conditions
Smoke studies were inadequately per fo nned under dynamic conditions. Specifically, Your fnm 's smoke studies do not include a full set up and simulation of processing within the ISO-5 space. Your fnm utilizes equipment within the ISO-5 space such as filling needle s tands and pumps/tubing that are not present in your fnm 's smoke studies. Your fnm 's cun ent smoke studies were per fo1med to show the trans fe r of vial bins between ISO-5 hoods and into the [(6) (2J) JAccording to your fnm 's Quality Director, this is the worst case challenge that compounding technicians could face. Routine production has not been simulated to dete1mine if smoke airflow is impacted fo r cunent processes and equipment in the ISO-5 area. In addition, turbulent air was observed during review of the most recent smoke study per fo nned on 2/1/2025 . *DATES OF INSPECTION EMPLOYE E(S) SIGNATURE DATE ISSUED SEE REVERSE Lo gan T Willi a.
What a Form 483 means
A Form FDA 483 is issued at the close of an FDA facility inspection to list conditions an investigator observed that may violate the Federal Food, Drug, and Cosmetic Act or its implementing regulations. It reflects the investigator's professional judgment at that point in time and is not a final agency determination, an enforcement action, or proof that a violation occurred. Firms are expected to respond in writing, typically within 15 business days, describing the corrective and preventive actions they plan to take. FDA reviews that response, along with any follow-up evidence, before deciding what happens next. Many 483s are resolved through corrective action alone. When FDA judges a firm's response inadequate, or when the underlying conditions are serious enough, the observations documented here can lead to a Warning Letter or further regulatory action. This page presents the observations exactly as recorded on the FDA-issued document; always confirm citation language against the original record before relying on it.
Pharmcore Inc. dba Hallandale Pharmacy’s FDA history
Argus HQ has recorded 1 total FDA action tied to Pharmcore Inc. dba Hallandale Pharmacy: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- What is an FDA Form 483?
- A Form FDA 483 lists an FDA investigator's written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.
- Does this Form 483 mean Pharmcore Inc. dba Hallandale Pharmacy violated the law?
- No. A Form 483 documents an investigator's observations only. FDA reviews the firm's written response and any corrective actions taken before deciding whether further action is warranted, and many 483s are closed without additional enforcement once a firm shows adequate correction.
- What happens after a Form 483 is issued?
- The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.
- Has Pharmcore Inc. dba Hallandale Pharmacy had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Pharmcore Inc. dba Hallandale Pharmacy so far. Argus ingests new FDA records daily.
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Related enforcement actions
Full FDA history for Pharmcore Inc. dba Hallandale PharmacyCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2025). June 13, 2025 FDA Form 483 for Pharmcore Inc. dba Hallandale Pharmacy — 2 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-pharmcore-inc-dba-hallandale-pharmacy-2025-06-13-3014480778
"June 13, 2025 FDA Form 483 for Pharmcore Inc. dba Hallandale Pharmacy — 2 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-pharmcore-inc-dba-hallandale-pharmacy-2025-06-13-3014480778.
Argus HQ Research. "June 13, 2025 FDA Form 483 for Pharmcore Inc. dba Hallandale Pharmacy — 2 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-pharmcore-inc-dba-hallandale-pharmacy-2025-06-13-3014480778.
@misc{argushq_argushq_ai_483_fda_483_pharmcore_inc_dba_hallandale_pharmacy_2025_06_13_3014480778_2025,
title = {June 13, 2025 FDA Form 483 for Pharmcore Inc. dba Hallandale Pharmacy — 2 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-pharmcore-inc-dba-hallandale-pharmacy-2025-06-13-3014480778},
note = {Accessed: July 15, 2026}
}