Enforcement record
Administrative Guidance disclosure naming 武田薬品工業株式会社
This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.
Action type
Administrative Guidance
Law
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
Authority
Ministry of Health, Labour and Welfare
Action date
30 August 2021
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, 04:11 PM JST
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Action summary
- Company
- 武田薬品工業株式会社Japanese onlyOriginal: 武田薬品工業株式会社
- 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
- 30 August 2021
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
- Industry context
- 医薬品製造
Violation
It is considered highly likely that foreign matter was introduced during the manufacturing process. The foreign matter is most likely fragments resembling rubber stoppers, and foreign objects were found inside the vials before puncture.
Show original Japanese text
製造工程において異物混入が発生した可能性が高いと考えられる。異物はゴム栓様の破片の可能性が高く、穿刺前のバイアル内に異物が発見された。
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.
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.