Key facts
| Firm | Sato Pharmaceutical Co., Ltd. |
|---|---|
| FEI / inspection ID | 3004055563 |
| Inspection end date | November 21, 2025 |
| Citation count | 1 |
Citations explained
Observation 1 — -- 1 of 10 -- -- 2 of 10 -- -- 3
-- 1 of 10 -- -- 2 of 10 -- -- 3 of 10 -- -- 4 of 10 -- -- 5 of 10 -- -- 6 of 10 -- -- 7 of 10 -- -- 8 of 10 -- -- 9 of 10 -- The observations of objectionable conditions and practices listed on the front of this form are reported: 1. Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or 2. To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration. Section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 USC 374(b)) provides: "Upon completion of any such inspection of a factory, warehouse, consulting laboratory, or other establishment, and prior to leaving the premises, the officer or employee making the inspection shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed by him which,.
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.
Sato Pharmaceutical Co., Ltd.’s FDA history
Argus HQ has recorded 2 total FDA actions tied to Sato Pharmaceutical Co., Ltd.: 1 warning letter, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- 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.
- 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 Sato Pharmaceutical Co., Ltd. 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.
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Related enforcement actions
Full FDA history for Sato Pharmaceutical Co., Ltd.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). FDA Form 483 — Sato Pharmaceutical Co., Ltd. (November 21, 2025) — 1 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-sato-pharmaceutical-co-ltd-2025-11-21-3004055563
"FDA Form 483 — Sato Pharmaceutical Co., Ltd. (November 21, 2025) — 1 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-sato-pharmaceutical-co-ltd-2025-11-21-3004055563.
Argus HQ Research. "FDA Form 483 — Sato Pharmaceutical Co., Ltd. (November 21, 2025) — 1 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-sato-pharmaceutical-co-ltd-2025-11-21-3004055563.
@misc{argushq_argushq_ai_483_fda_483_sato_pharmaceutical_co_ltd_2025_11_21_3004055563_2025,
title = {FDA Form 483 — Sato Pharmaceutical Co., Ltd. (November 21, 2025) — 1 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-sato-pharmaceutical-co-ltd-2025-11-21-3004055563},
note = {Accessed: July 15, 2026}
}