Possible Business Improvement Order against 沢井製薬株式会社九州工場
For developers: integration details
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/api/v1/enforcements?company=%E6%B2%A2%E4%BA%95%E8%A3%BD%E8%96%AC%E6%A0%AA%E5%BC%8F%E4%BC%9A%E7%A4%BE%E4%B9%9D%E5%B7%9E%E5%B7%A5%E5%A0%B4&limit=10Action summary
- Company
- 沢井製薬株式会社九州工場Japanese originalOriginal: 沢井製薬株式会社九州工場
- Entity match
- Possible entity match60/100Machine extractedCompany name extracted from the Japanese public disclosure
- Governing law
- 医薬品医療機器等法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
Violation
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-highA formal order requiring business process or compliance control improvements.
Japanese regulatory disclosure under 医薬品医療機器等法.
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.
Evidence pack
- Extracted at
- 2026-04-24T23:37:38.968+00:00
- Evidence checked
- 2026-04-24T23:37:38.968+00:00
- Archive captured
- 2026-04-03T12:30:42.71+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": "沢井製薬株式会社九州工場",
"corporate_number": null,
"law": {
"ja": "医薬品医療機器等法",
"en": "医薬品医療機器等法"
},
"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": "possible",
"confidence": 60,
"method": "extracted_japanese_name",
"method_label": "Company name extracted from the Japanese public disclosure",
"notes": null
},
"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 医薬品医療機器等法."
},
"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",
"archiveUrl": "https://kiroku.today/view/fde22bcd3civtkgt",
"archiveCapturedAt": "2026-04-03T12:30:42.71+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": "2026-06-19T09:18:42.654Z"
},
"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
- 沢井製薬株式会社九州工場 Japanese original
- Japanese name
- 沢井製薬株式会社九州工場
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.