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
Current page: Enforcement record
This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.
Source verification
Public-source and preservation status
- Publishing authority
- Ministry of Health, Labour and Welfare
- Official source URL
- Recorded by RegBase
- Entity match
- Not confirmed; shown under the published name
- Kiroku preservation
- Queued for preservation
- Captured: Jul 12, 2026, 03:22 PM JST
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Public documents and saved materials
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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.
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.