Directive against 一般財団法人化学及血清療法研究所

一般財団法人化学及血清療法研究所 (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices)

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and WelfareConfirmed entity match5 June 2015

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/api/v1/enforcements?corporate_number=6330005006672&limit=10

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Action summary

Company: 一般財団法人化学及血清療法研究所Japanese original
Original: 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 extracted
Normalized Japanese name matched to a company profile with Corporate Number
Matched 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: Directive
指示
Action date: 5 June 2015
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

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

Medium

A 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

Original Ministry of Health, Labour and Welfare announcement (Japanese)Archived source snapshot

Extracted at: 2026-04-24T23:33:49.434+00:00
Evidence checked: 2026-04-24T23:33:49.434+00:00
Archive captured: 2026-04-04T00:30:59.531+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": "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": "指示",
      "en": "Directive"
    },
    "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": "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",
    "archiveUrl": "https://kiroku.today/view/668bb614ccjljusc",
    "archiveCapturedAt": "2026-04-04T00:30:59.531+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": "2026-06-19T09:20:21.871Z"
  },
  "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

See company profile →

About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.