Enforcement record
Administrative Guidance disclosure naming ファイザー株式会社
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
15 September 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
- Completed archive verified
- Captured: Jul 12, 2026, 04:21 PM JST
“Confirmed” means that RegBase matched this record to the cited public disclosure or entity under the stated checks. It does not verify the truth of the disclosure or guarantee the entity’s current status, creditworthiness, or any legal conclusion.
Open the official source links in the section below to review the original disclosure.
Action summary
- Company
- ファイザー株式会社Japanese onlyOriginal: ファイザー株式会社
- 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
- 15 September 2021
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
- Industry context
- 医薬品製造
Violation
The formulation may contain white particles (floaters) derived from the product, but when diluted and dissolved, it can be used without issue. During dilution, gently invert the vial 10 times before and after dilution. Occasionally, even after dilution and gentle inversion, white particles derived from the product may remain undissolved. In such cases, do not use the vial with the residual particles and use another vial. The white particulate matter derived from the product is not associated with safety concerns. No extraneous foreign matter has been confirmed among the reported white particulate matter. Regarding the white particulate matter reported in multiple cases from different municipalities for lot number FF5357, investigations are ongoing. The results will be promptly announced and reported to the Ministry of Health, Labour and Welfare.
Show original Japanese text
製剤特性として製品由来の白色の微粒子（浮遊物）を含むことがあるが、希釈し溶解した場合は問題なく使用可能。希釈時は、希釈前及び希釈後に、ゆっくりと10回転倒混和すること。稀に、希釈後、転倒混和しても、製品由来の白色の微粒子（浮遊物）が溶解せずに残ることがある。その場合は当該バイアルは使用せず、他のバイアルを使用すること。なお、製品由来の白色浮遊物は安全性への影響はない。これまでに白色浮遊物として報告されたもので外来性の異物は確認されていない。既にロット番号「FF5357」に関し、複数の自治体より相談されている白色浮遊物については、調査中であり、結果については速やかに公表し、厚労省に報告する。
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.
Open original sources and verification detailsOfficial URL, direct PDF, and Kiroku archive
- Extracted at
- 2026-04-25T00:19:53.731+00:00
- Evidence checked
- 2026-04-25T00:19:53.731+00:00
- Archive captured
- 2026-07-12T07:21:06.666665+00:00
Show audit JSON
{
"record": {
"id": "bfaa7791-76ff-44ee-b886-0a879828a8c7",
"url": "https://regbase.jp/en/enforcement/yakkiho-huaiza-20210915",
"company_name_original": "ファイザー株式会社",
"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": "行政指導",
"en": "Administrative Guidance"
},
"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 (ファイザー株式会社). No Corporate Number was present in the disclosure, so this remains a likely match."
},
"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-huaiza-20210915",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_21115.html",
"officialDocumentUrl": null,
"archiveUrl": "https://kiroku.today/a/9d3d9463edhgrhvi",
"archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_21115.html",
"archiveCapturedAt": "2026-07-12T07:21:06.666665+00:00",
"extractedAt": "2026-04-25T00:19:53.731+00:00",
"translatedAt": "2026-05-01T07:08:22.354+00:00",
"evidenceCheckedAt": "2026-04-25T00:19:53.731+00:00",
"generatedAt": "2026-09-18T20:14:53.980Z"
},
"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.