Key facts
| Firm | Astellas Pharma Inc. |
|---|---|
| FEI / inspection ID | 3002807001 |
| Inspection end date | June 6, 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 D I
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION D I STRICT ADDRESS ANO PH ONE NUMBER 10903 New Hampshire Avenue Building 51 Silver Spring, MD 20993 301 - 796 - 3150 Fax : (301) 59 4- 120 4 OATE(S) OF INSPECTION 6/2/2025 - 6/6/2025 FEJNUMBER 3002807001 NAM E AND TITLE OF I NDIVIDUAL TO WHOM REPORT ISSUED Dr . Masafumi Dohi, Execu t ive Direc t or & General Manager F IRM NAME Ast ellas Pharma I nc . STREET ADDRESS Sakae - Machi 30, Toide CITY . STATE. ZIP CODE. COUITTRY Takaoka, Toyama, 939 - 1118 Japan TYPE ESTABUSI-NE NT INSPECTED St erile Drug Produc t Manufac t urer This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency detemiination regarding your compliance. If you have an objection regarding an observation, or have in1plemente d, or plan to implement, corrective action.
Astellas Pharma Inc.’s FDA history
Argus HQ has recorded 1 total FDA action tied to Astellas Pharma Inc.: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- Does this Form 483 mean Astellas Pharma Inc. 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 Astellas Pharma Inc. had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Astellas Pharma Inc. so far. Argus ingests new FDA records daily.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3002807001.
See if this 483 escalates to a warning letter — before your auditor asks.
Free weekly briefing tracks every FDA inspection outcome.
Related enforcement actions
Full FDA history for Astellas Pharma Inc.Compiled 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). Astellas Pharma Inc. — FDA Form 483 Inspection, June 6, 2025 (1 Citations). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-astellas-pharma-inc-2025-06-06-3002807001
"Astellas Pharma Inc. — FDA Form 483 Inspection, June 6, 2025 (1 Citations)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-astellas-pharma-inc-2025-06-06-3002807001.
Argus HQ Research. "Astellas Pharma Inc. — FDA Form 483 Inspection, June 6, 2025 (1 Citations)." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-astellas-pharma-inc-2025-06-06-3002807001.
@misc{argushq_argushq_ai_483_fda_483_astellas_pharma_inc_2025_06_06_3002807001_2025,
title = {Astellas Pharma Inc. — FDA Form 483 Inspection, June 6, 2025 (1 Citations)},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-astellas-pharma-inc-2025-06-06-3002807001},
note = {Accessed: July 15, 2026}
}