Administrative Guidance against 一般財団法人化学及血清療法研究所
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/api/v1/enforcements?corporate_number=6330005006672&limit=10Action summary
- Company
- 一般財団法人化学及血清療法研究所Japanese originalOriginal: 一般財団法人化学及血清療法研究所Corporate Number: 6330005006672
- Entity match
- Confirmed entity match95/100Machine extractedNormalized Japanese name matched to a company profile with Corporate NumberMatched by normalized Japanese company name to an enriched company profile with a Corporate Number.
- Governing law
- Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices薬機法
- Action type
- Administrative Guidance行政指導
- Action date
- 21 October 2015
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
It was found that appropriate reports had not been made to the Ministry of Health, Labour and Welfare regarding discrepancies between the approval document and manufacturing practices. Consequently, on September 18, a request was made to suspend shipments and to submit proper reports. Subsequently, the Ministry of Health, Labour and Welfare reviewed the reported information.
Show original Japanese text
承認書と製造実態の齟齬等についての厚生労働省への報告が適切になされていないことが判明したことから、９月18日付けで出荷の自粛を要請するとともに適切な報告を求め、その後厚生労働省において報告内容の精査を行ってきました。
Compliance context
Low-mediumAdministrative guidance or supervision was publicly disclosed by the authority.
Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising.
Use as a monitoring signal. Confirm details before treating it as a formal sanction.
This context is an operational aid for review workflows, not a credit opinion or legal conclusion.
Evidence pack
- Extracted at
- 2026-04-25T00:23:24.749+00:00
- Evidence checked
- 2026-04-25T00:23:24.749+00:00
- Archive captured
- 2026-04-15T18:01:36.473+00:00
Show audit JSON
{
"record": {
"id": "39ef3e8b-3cb2-4b85-a197-f153d7a5bfe3",
"url": "https://regbase.jp/en/enforcement/yakkiho-hua-xue-ji-xie-qing-liao-fa-yan-jiu-suo-20151021",
"company_name_original": "一般財団法人化学及血清療法研究所",
"company_name_registry": "一般財団法人化学及血清療法研究所",
"corporate_number": "6330005006672",
"law": {
"ja": "薬機法",
"en": "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices"
},
"action_type": {
"ja": "行政指導",
"en": "Administrative Guidance"
},
"authority": {
"ja": "厚生労働省",
"en": "Ministry of Health, Labour and Welfare"
}
},
"entity_match": {
"status": "confirmed",
"confidence": 95,
"method": "normalized_name_with_corporate_number",
"method_label": "Normalized Japanese name matched to a company profile with Corporate Number",
"notes": "Matched by normalized Japanese company name to an enriched company profile with a Corporate Number."
},
"review": {
"status": "unreviewed",
"label": "Machine extracted"
},
"compliance_context": {
"severity": "Low-medium",
"actionMeaning": "Administrative guidance or supervision was publicly disclosed by the authority.",
"practicalNote": "Use as a monitoring signal. Confirm details before treating it as a formal sanction.",
"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-20151021",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000101868.html",
"archiveUrl": "https://kiroku.today/view/419e211c600cxbmd",
"archiveCapturedAt": "2026-04-15T18:01:36.473+00:00",
"extractedAt": "2026-04-25T00:23:24.749+00:00",
"translatedAt": "2026-05-01T07:11:33.652+00:00",
"evidenceCheckedAt": "2026-04-25T00:23:24.749+00:00",
"generatedAt": "2026-06-19T09:19:20.033Z"
},
"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)Company info
- English name
- 一般財団法人化学及血清療法研究所 Japanese original
- Japanese name
- 一般財団法人化学及血清療法研究所
- Corporate Number
- 6330005006672
- Registered address
- 熊本県熊本市中央区新市街８番７号
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.