Administrative Guidance against 小林化工株式会社
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/api/v1/enforcements?corporate_number=6210001007109&limit=10Action summary
- Company
- 小林化工株式会社Japanese originalOriginal: 小林化工株式会社Corporate Number: 6210001007109
- Entity match
- Confirmed entity match95/100Machine extractedNormalized Japanese name matched to a company profile with Corporate NumberMatched 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
- 16 April 2021
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Regarding stability testing for the approval application, the dates of stability testing and analysis method validation were falsified. Stability tests were conducted on formulations manufactured by methods different from those described in the approval application.
Show original Japanese text
承認申請用の安定性試験について、安定性試験の実施日、分析法バリデーションの実施日等を改ざんしていた。承認申請書の記載とは異なる方法で製造された製剤で、承認申請用の安定性試験を行っていた。
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.
Evidence pack
- Extracted at
- 2026-04-24T23:36:26.322+00:00
- Evidence checked
- 2026-04-24T23:36:26.322+00:00
- Archive captured
- 2026-04-03T12:31:02.593+00:00
Show audit JSON
{
"record": {
"id": "ed2ced99-f6c1-4f8e-8ceb-f9480a4bbf1f",
"url": "https://regbase.jp/en/enforcement/yakkiho-xiao-lin-hua-gong-20210416",
"company_name_original": "小林化工株式会社",
"company_name_registry": "小林化工株式会社",
"corporate_number": "6210001007109",
"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-xiao-lin-hua-gong-20210416",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_18128.html",
"archiveUrl": "https://kiroku.today/view/6c50a95254ivtzt7",
"archiveCapturedAt": "2026-04-03T12:31:02.593+00:00",
"extractedAt": "2026-04-24T23:36:26.322+00:00",
"translatedAt": "2026-05-01T06:51:14.578+00:00",
"evidenceCheckedAt": "2026-04-24T23:36:26.322+00:00",
"generatedAt": "2026-06-19T09:16:20.832Z"
},
"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
- 小林化工株式会社 Japanese original
- Japanese name
- 小林化工株式会社
- Corporate Number
- 6210001007109
- Registered address
- 福井県あわら市矢地第9号17番地8
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.