承認取消及び業務改善命令 against 小林化工株式会社

小林化工株式会社 (医薬品医療機器等法)
医薬品医療機器等法Ministry of Health, Labour and WelfareConfirmed entity match28 April 2021
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/api/v1/enforcements?corporate_number=6210001007109&limit=10

Action summary

Company
小林化工株式会社Japanese original
Original: 小林化工株式会社
Corporate Number: 6210001007109
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
医薬品医療機器等法
医薬品医療機器等法
Action type
承認取消及び業務改善命令
承認取消及び業務改善命令
Action date
28 April 2021
Issuing authority
Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

The Ministry of Health, Labour and Welfare has today issued an administrative disposition to Kobayashi Kako Co., Ltd., including approval cancellation based on Article 74-2, Paragraph 3, Item 2 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, and a business improvement order based on Article 72-4, Paragraph 1 of the same Act, as detailed in the attached document.

Show original Japanese text

厚生労働省では、本日付で、小林化工株式会社に対し別紙の通り、医薬品医療機器等法第74条の2第3項第2号の規定に基づく承認取消及び同法第72条の4第1項に基づく業務改善命令(行政処分)を行いましたので、お知らせします。

Compliance context

Context needed

This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.

Japanese regulatory disclosure under 医薬品医療機器等法.

Review the original Japanese source and determine relevance to your counterparty-risk workflow.

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
2026-04-24T23:36:21.54+00:00
Evidence checked
2026-04-24T23:36:21.54+00:00
Archive captured
2026-04-03T12:31:04.451+00:00
Show audit JSON
{
  "record": {
    "id": "7893ba64-10e4-47ec-9e40-95f17f27edbd",
    "url": "https://regbase.jp/en/enforcement/other-xiao-lin-hua-gong-20210428",
    "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": "医薬品医療機器等法",
      "en": "医薬品医療機器等法"
    },
    "action_type": {
      "ja": "承認取消及び業務改善命令",
      "en": "承認取消及び業務改善命令"
    },
    "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": "Context needed",
    "actionMeaning": "This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.",
    "practicalNote": "Review the original Japanese source and determine relevance to your counterparty-risk workflow.",
    "lawContext": "Japanese regulatory disclosure under 医薬品医療機器等法."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-xiao-lin-hua-gong-20210428",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_18351.html",
    "archiveUrl": "https://kiroku.today/view/dcd5dac040ivu187",
    "archiveCapturedAt": "2026-04-03T12:31:04.451+00:00",
    "extractedAt": "2026-04-24T23:36:21.54+00:00",
    "translatedAt": "2026-05-01T06:51:11.307+00:00",
    "evidenceCheckedAt": "2026-04-24T23:36:21.54+00:00",
    "generatedAt": "2026-06-19T11:01:48.128Z"
  },
  "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.

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
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.