Key facts
| Firm | Sterling Distributors, LLC |
|---|---|
| FEI / inspection ID | 3007309337 |
| Inspection end date | March 6, 2025 |
| Citation count | 1 |
Citations explained
Observation 1 — ----- --------- ---- DEPARTM ENT OF HEAL TH AND HUMA N SERVICES
----- --------- ---- DEPARTM ENT OF HEAL TH AND HUMA N SERVICES rooo /\ND DRUG /\OMINISfR/1 TION DISTRh.1 o• n.,E ADDRESS ANO PHO~E NUMBER DA TE(S) OF l'ISPECTIO~I Florida 01stnc1 Office OJ 03/2025-03/06/2025 :, ~5 \\ indcrle} PL Maitland H. •Z751 FEINUM8ER Phont' . 407-•17<;•4200 3007309137 lndu~II} Information:"" w.fda.gov,oc/mdustry NAM[ ANO T TLE OF INDIVIDUAL TO WHOM REPORT IS ISSUE~D------ ______.____ TO: Dean Bert) , President FIRM NAM( STREET ADDRESS Sterling D1s1ributors. I.I C 4381 NW 124 Ave CITY STATE ANO 21P CODE --+-T-YP-E OF ESTABLI-SH_M_E_NT_IN_S_P_EC,,-T-EO-- Coral Springs, FL 33065 Distributor THIS DOCUMENT LISTS OBSERVATIONS MADE BY THE FDA RE,;;ESENTATIVE(S) DURING THE INSPECTION OF YOUR FACILITY ~RE INSPECTIONAL OBSERVATIONS, ANO DO NOT REPRESE~T A FINAL AGENCY DETERMINATION REGARDING YOUR COMPLIANCE IF YOU HAVE AN OBJECTION REGARDING AN OBSERVATION. OR HAVE IMPLEMENTED. OR PLAN TO IMPLEMENT CORRECTIVE ACTION IN RESPONSE TO AN OBSERVATION, YOU MAY DISCUSS T"E 08.:ECTION OR ACTION WITH THE FDA REPRESENTATIVE($) DURING THE INSPECTION OR SUBMIT THIS INFORMATION.
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.
Sterling Distributors, LLC’s FDA history
Argus HQ has recorded 1 total FDA action tied to Sterling Distributors, LLC: 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 Sterling Distributors, LLC 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 Sterling Distributors, LLC had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Sterling Distributors, LLC so far. Argus ingests new FDA records daily.
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Related enforcement actions
Full FDA history for Sterling Distributors, LLCCompiled 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). March 6, 2025 FDA Form 483 for Sterling Distributors, LLC — 1 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-sterling-distributors-llc-2025-03-06-3007309337
"March 6, 2025 FDA Form 483 for Sterling Distributors, LLC — 1 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-sterling-distributors-llc-2025-03-06-3007309337.
Argus HQ Research. "March 6, 2025 FDA Form 483 for Sterling Distributors, LLC — 1 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-sterling-distributors-llc-2025-03-06-3007309337.
@misc{argushq_argushq_ai_483_fda_483_sterling_distributors_llc_2025_03_06_3007309337_2025,
title = {March 6, 2025 FDA Form 483 for Sterling Distributors, LLC — 1 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-sterling-distributors-llc-2025-03-06-3007309337},
note = {Accessed: July 15, 2026}
}