Enforcement record

Business Improvement Order disclosure naming 沢井製薬株式会社九州工場

沢井製薬株式会社九州工場 (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices)

This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and WelfareGovernment disclosure22 December 2023

Action type

Business Improvement Order

Law

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices

Authority

Ministry of Health, Labour and Welfare

Action date

22 December 2023

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, 03:35 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: 沢井製薬株式会社九州工場Japanese only
Original: 沢井製薬株式会社九州工場
Governing law: Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
医薬品医療機器等法
Action type: Business Improvement Order
業務改善命令
Action date: 22 December 2023
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省
Industry context: 医薬品製造

Violation

Machine-translated summary — verify against original

In the quality testing of the pharmaceutical product, a testing method different from that approved (replacing the drug into a different capsule before performing dissolution testing) was carried out.

Show original Japanese text

医薬品の品質試験において、承認書と異なる試験方法（別のカプセルに薬剤を詰め替えた上で溶出性試験を行っていた。）が実施されていた。

Compliance context

Medium-high

A formal order requiring business process or compliance control improvements.

Japanese regulatory disclosure under Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices.

Ask for remediation evidence if the company is material to your compliance, finance, or customer-facing operations.

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

Original Ministry of Health, Labour and Welfare source (Japanese)Open preserved source and evidence pack

Extracted at: 2026-04-24T23:37:38.968+00:00
Evidence checked: 2026-04-24T23:37:38.968+00:00
Archive captured: 2026-07-12T06:35:28.645864+00:00

Show audit JSON

{
  "record": {
    "id": "2ef899cd-84a5-469c-91e9-74c8b30c620d",
    "url": "https://regbase.jp/en/enforcement/other-ze-jing-zhi-yao-jiu-zhou-gong-chang-20231222",
    "company_name_original": "沢井製薬株式会社九州工場",
    "company_name_registry": null,
    "corporate_number": null,
    "law": {
      "ja": "医薬品医療機器等法",
      "en": "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices"
    },
    "action_type": {
      "ja": "業務改善命令",
      "en": "Business Improvement Order"
    },
    "authority": {
      "ja": "厚生労働省",
      "en": "Ministry of Health, Labour and Welfare"
    }
  },
  "entity_match": {
    "status": "unresolved",
    "confidence": 60,
    "method": "extracted_japanese_name",
    "method_label": "Company name extracted from the Japanese public disclosure",
    "notes": "The linked company profile has not been verified under the current identity policy."
  },
  "review": {
    "status": "unreviewed",
    "label": "Machine extracted"
  },
  "compliance_context": {
    "severity": "Medium-high",
    "actionMeaning": "A formal order requiring business process or compliance control improvements.",
    "practicalNote": "Ask for remediation evidence if the company is material to your compliance, finance, or customer-facing operations.",
    "lawContext": "Japanese regulatory disclosure under Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-ze-jing-zhi-yao-jiu-zhou-gong-chang-20231222",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_37021.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/fde22bcd3chf0jco",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_37021.html",
    "archiveCapturedAt": "2026-07-12T06:35:28.645864+00:00",
    "extractedAt": "2026-04-24T23:37:38.968+00:00",
    "translatedAt": "2026-05-01T06:51:48.542+00:00",
    "evidenceCheckedAt": "2026-04-24T23:37:38.968+00:00",
    "generatedAt": "2026-09-18T20:03:55.571Z"
  },
  "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.