Key facts
| Firm | Allergan Pharmaceuticals Ireland Unlimited |
|---|---|
| FEI / inspection ID | 3002806285 |
| Inspection end date | January 30, 2025 |
| Citation count | 1 |
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.
Citations explained
Observation 1 — DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS AND PHONE NUMBER CDER/OPQ/OPMA/DPMA Attn: Ch ristopher Downey, Ph.D., Division Director 10903 New Hampshire Avenue; White Oak Bui lding 51/Room 2269 Silver Spring, MD 20993-0002 E-ma il: OPMABLA1nspect ion483Responses@fda.hhs.gov OATE(S) OF INSPECTION 01/23/2025-01/30/2025 F EI NUMBER 3002806285 NAME A NO TITLE OF INOM OU AL TO WH OM REPORT ISSUED Benjamin Schroeder, Si te Dir ector FIRM NAME A llergan Pharmaceut icals I re l and Un limi ted STREET AOORESS Castlebar Road CITY. STATE. ZIP CODE. COUNTRY Westport Co . Mayo F28 AW83, Ireland TYPE ESTABLISHMENT INSPECTED Drug Product Manufacturer This document l
Allergan Pharmaceuticals Ireland Unlimited’s FDA history
Argus HQ has recorded 1 total FDA action tied to Allergan Pharmaceuticals Ireland Unlimited: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- Has Allergan Pharmaceuticals Ireland Unlimited had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Allergan Pharmaceuticals Ireland Unlimited so far. Argus ingests new FDA records daily.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3002806285.
- Is a Form 483 the same as a Warning Letter?
- No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.
- Where can I read the full Form 483?
- The verbatim inspection record is the source of truth — always confirm citation language against the original FDA document before acting.
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Related enforcement actions
Full FDA history for Allergan Pharmaceuticals Ireland UnlimitedCompiled 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). January 30, 2025 FDA Form 483 for Allergan Pharmaceuticals Ireland Unlimited — 1 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-allergan-pharmaceuticals-ireland-unlimited-2025-01-30-3002806285
"January 30, 2025 FDA Form 483 for Allergan Pharmaceuticals Ireland Unlimited — 1 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-allergan-pharmaceuticals-ireland-unlimited-2025-01-30-3002806285.
Argus HQ Research. "January 30, 2025 FDA Form 483 for Allergan Pharmaceuticals Ireland Unlimited — 1 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-allergan-pharmaceuticals-ireland-unlimited-2025-01-30-3002806285.
@misc{argushq_argushq_ai_483_fda_483_allergan_pharmaceuticals_ireland_unlimited_2025_01_30_3002806285_2025,
title = {January 30, 2025 FDA Form 483 for Allergan Pharmaceuticals Ireland Unlimited — 1 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-allergan-pharmaceuticals-ireland-unlimited-2025-01-30-3002806285},
note = {Accessed: July 15, 2026}
}