Key facts
| Firm | Asahi Kasei Finechem Co., Ltd. |
|---|---|
| FEI / inspection ID | 3002806404 |
| Inspection end date | November 14, 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 — Methods used in testing must meet proper standards of accuracy and reliability
Methods used in testing must meet proper standards of accuracy and reliability as applied to the product tested. Specifically, Your firm has not performed method validation studies on in-house developed test method, , nor method ,x e.riftcatio.n...s tudies o.n......U__S_£__m_ethods. usedJ o oerfonn.finished or.oduc_t r.elease te.stimz: on(b> fI drug products0000 00 manufactured for the 1----------------------------------------- us market. A) The following are examples of unvalidated in-house analytical methods used for finished product release testing: 1. Heavy Metals Method used for testing~H4> I 2. E. coli Method used for testing~H4> l~---- 3. Salmonella Species method used for testing ~><4> I B) The following are examples of unverified USP analytical methods used for finished product release testing: 1. Loss on Drying (LOO) USP method for ~H4) I 2. Identification (IR) USP method for(bH4> ~....._ __ _ 3. Loss on Drying (LOO) USP method fo q 1>><4> I This failure compromises your firm's ability to demonstrate that test results accurately reflect product quality and compliance.
Asahi Kasei Finechem Co., Ltd.’s FDA history
Argus HQ has recorded 1 total FDA action tied to Asahi Kasei Finechem Co., Ltd.: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- Does this Form 483 mean Asahi Kasei Finechem 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.
- Has Asahi Kasei Finechem Co., Ltd. had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Asahi Kasei Finechem Co., Ltd. so far. Argus ingests new FDA records daily.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3002806404.
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Related enforcement actions
Full FDA history for Asahi Kasei Finechem 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). Asahi Kasei Finechem Co., Ltd. — FDA Form 483 Inspection, November 14, 2025 (1 Citations). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-asahi-kasei-finechem-co-ltd-2025-11-14-3002806404
"Asahi Kasei Finechem Co., Ltd. — FDA Form 483 Inspection, November 14, 2025 (1 Citations)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-asahi-kasei-finechem-co-ltd-2025-11-14-3002806404.
Argus HQ Research. "Asahi Kasei Finechem Co., Ltd. — FDA Form 483 Inspection, November 14, 2025 (1 Citations)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-asahi-kasei-finechem-co-ltd-2025-11-14-3002806404.
@misc{argushq_argushq_ai_483_fda_483_asahi_kasei_finechem_co_ltd_2025_11_14_3002806404_2025,
title = {Asahi Kasei Finechem Co., Ltd. — FDA Form 483 Inspection, November 14, 2025 (1 Citations)},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-asahi-kasei-finechem-co-ltd-2025-11-14-3002806404},
note = {Accessed: July 13, 2026}
}