Administrative Guidance against ファイザー株式会社

ファイザー株式会社 (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 match15 September 2021

For developers: integration details

You do not need this for normal browsing. Use it when integrating this enforcement record into an internal tool or AI workflow.

/api/v1/enforcements?corporate_number=5011001126167&limit=10

Open API response API docs

Action summary

Company: ファイザー株式会社Japanese original
Original: ファイザー株式会社
Corporate Number: 5011001126167
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: Administrative Guidance
行政指導
Action date: 15 September 2021
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

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-medium

Administrative 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

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

Extracted at: 2026-04-25T00:19:53.731+00:00
Evidence checked: 2026-04-25T00:19:53.731+00:00
Archive captured: 2026-04-09T18:01:06.175+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": "ファイザー株式会社",
    "corporate_number": "5011001126167",
    "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-huaiza-20210915",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_21115.html",
    "archiveUrl": "https://kiroku.today/view/9d3d9463edrs9kc6",
    "archiveCapturedAt": "2026-04-09T18:01:06.175+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": "2026-06-28T18:06:58.226Z"
  },
  "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: ファイザー株式会社 Japanese original
Japanese name: ファイザー株式会社
Corporate Number: 5011001126167
Registered address: 東京都渋谷区代々木３丁目２２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.