Enforcement record
Directive disclosure naming 一般財団法人化学及血清療法研究所
This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.
Action type
Directive
Law
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
Authority
Ministry of Health, Labour and Welfare
Action date
5 June 2015
RegBase evidence report
Japanese public-record enforcement check
Saveable record of the published action, regulator source, source status, and review notes for internal compliance files.
- Report ID
- RB-EN-ENFORCEMENT-YAKKIHO-HUA-XUE-J-202608041532
- Generated at
- 5 August 2026 at 00:32
- Record URL
- https://regbase.jp/en/enforcement/yakkiho-hua-xue-ji-xie-qing-liao-fa-yan-jiu-suo-20150605
1. Review Summary
| Disclosure name | 一般財団法人化学及血清療法研究所 | Corporate Number | Not stated in the disclosure |
|---|---|---|---|
| Enforcement record | 1 record | Other confirmed records for this company | Outside this report's scope |
| Action date | 5 June 2015 | Authority | Ministry of Health, Labour and Welfare |
| Law | Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices | Action type | Directive |
| Source status | Preserved public-source archive recorded | ||
This report summarizes public Japanese government disclosure data held by RegBase. It is not a credit score, sanctions conclusion, legal opinion, or adverse-media determination. Confirm important decisions against the linked official Japanese source.
2. Published Information
| Published name | 一般財団法人化学及血清療法研究所 |
|---|
3. Enforcement Record
| Target name in disclosure | 一般財団法人化学及血清療法研究所 |
|---|---|
| Authority | Ministry of Health, Labour and Welfare (厚生労働省) |
| Law / action type | Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices / Directive |
| Action / announcement date | Action: 5 June 2015 / Announcement: 26 March 2026 |
| English summary | It was found that the product was manufactured using a method different from the approved method. - Heparin was added without being listed in the approval document. - Additives were used in quantities different from those specified in the approval document. - Some steps in the manufacturing process described in the approval document were modified or omitted. |
| Original Japanese text | 承認書と異なる製造方法により製造されていることが判明しました。・ 承認書に記載していないヘパリンを添加。・ 承認書に記載された量と異なる添加剤を使用。・ 承認書に記載された工程を一部改変・省略。 |
| Official source | https://www.mhlw.go.jp/stf/houdou/0000088175.html |
| Source archive | https://kiroku.today/a/668bb614cchemef8 |
| Extraction / evidence timestamps | Extracted: 25 April 2026 at 08:33 / Evidence checked: 25 April 2026 at 08:33 / Archive captured: 12 July 2026 at 15:22 |
4. Business Location and Permit Details
No additional structured business-location or permit fields are recorded for this disclosure.
5. Other Confirmed Records for This Company
This report covers the single government disclosure shown on this page.
Reviewer Notes
| Reviewer | Team / company | ||
|---|---|---|---|
| Review purpose | |||
| Additional notes | |||
- □ Official source URL or archived source was checked.
- □ Corporate Number, address, or other identifiers were reviewed to avoid confusing similarly named entities.
- □ This document is understood as a public-record evidence file, not a credit decision or legal opinion.
Current page: Enforcement record
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Preserved evidence by Kiroku
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Action summary
- Company
- 一般財団法人化学及血清療法研究所Japanese onlyOriginal: 一般財団法人化学及血清療法研究所
- Governing law
- Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices薬機法
- Action type
- Directive指示
- Action date
- 5 June 2015
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
It was found that the product was manufactured using a method different from the approved method. - Heparin was added without being listed in the approval document. - Additives were used in quantities different from those specified in the approval document. - Some steps in the manufacturing process described in the approval document were modified or omitted.
Show original Japanese text
承認書と異なる製造方法により製造されていることが判明しました。・ 承認書に記載していないヘパリンを添加。・ 承認書に記載された量と異なる添加剤を使用。・ 承認書に記載された工程を一部改変・省略。
Compliance context
MediumA regulator issued a directive requiring specified action.
Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising.
Verify the required action and whether the company has disclosed remediation or completion.
This context is an operational aid for review workflows, not a credit opinion or legal conclusion.
Evidence pack
- Extracted at
- 2026-04-24T23:33:49.434+00:00
- Evidence checked
- 2026-04-24T23:33:49.434+00:00
- Archive captured
- 2026-07-12T06:22:57.098+00:00
Show audit JSON
{
"record": {
"id": "d12e0c0e-617e-4d09-87fb-4adadc2f5731",
"url": "https://regbase.jp/en/enforcement/yakkiho-hua-xue-ji-xie-qing-liao-fa-yan-jiu-suo-20150605",
"company_name_original": "一般財団法人化学及血清療法研究所",
"company_name_registry": null,
"corporate_number": null,
"law": {
"ja": "薬機法",
"en": "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices"
},
"action_type": {
"ja": "指示",
"en": "Directive"
},
"authority": {
"ja": "厚生労働省",
"en": "Ministry of Health, Labour and Welfare"
}
},
"entity_match": {
"status": "unresolved",
"confidence": 85,
"method": "nta_strict_name_nationally_unique",
"method_label": "nta_strict_name_nationally_unique",
"notes": "NTA full-download lookup found a nationally unique exact registered-name candidate (一般財団法人化学及血清療法研究所). No Corporate Number was present in the disclosure, so this remains a likely match."
},
"review": {
"status": "unreviewed",
"label": "Machine extracted"
},
"compliance_context": {
"severity": "Medium",
"actionMeaning": "A regulator issued a directive requiring specified action.",
"practicalNote": "Verify the required action and whether the company has disclosed remediation or completion.",
"lawContext": "Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising."
},
"evidence": {
"recordUrl": "https://regbase.jp/en/enforcement/yakkiho-hua-xue-ji-xie-qing-liao-fa-yan-jiu-suo-20150605",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000088175.html",
"officialDocumentUrl": null,
"archiveUrl": "https://kiroku.today/a/668bb614cchemef8",
"archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000088175.html",
"archiveCapturedAt": "2026-07-12T06:22:57.098+00:00",
"extractedAt": "2026-04-24T23:33:49.434+00:00",
"translatedAt": "2026-05-01T06:49:46.657+00:00",
"evidenceCheckedAt": "2026-04-24T23:33:49.434+00:00",
"generatedAt": "2026-08-04T15:32:30.851Z"
},
"limitations": [
"RegBase aggregates public Japanese government disclosures and does not provide a credit opinion.",
"English summaries are provided for reference. The original Japanese source is authoritative.",
"Possible or unresolved entity matches should be manually verified before use in a decision."
]
}The original Japanese disclosure is the authoritative record. Use possible or unresolved matches only as leads for manual review.
Language
日本語版を見る (Japanese)About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.