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小林化工株式会社

小林化工株式会社· Corporate Number: 6210001007109

小林化工株式会社は福井県あわら市に本店を置く企業であり、業種は不明である。2021年4月に医薬品医療機器等法および薬機法に関する行政処分を受けている。

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Public Record Summary

Actions in last 3 years
0records
Actions in last year
0records
Latest action
about 5 years ago

28 Apr 2021

Total penalties
-

Repeated actions: 7 actions are recorded for this company. Multiple actions under the same law may be relevant when reviewing repeat compliance issues.

Enforcement and administrative action history

医薬品医療機器等法承認取消及び業務改善命令
Confirmed entity match

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.

28 Apr 2021Ministry of Health, Labour and Welfare
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Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesAdministrative Guidance
Confirmed entity match

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.

16 Apr 2021Ministry of Health, Labour and Welfare
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医薬品医療機器等法Business Suspension Order
Confirmed entity match

Based on the Pharmaceuticals and Medical Devices Act, orders to suspend operations and improve business practices were issued for Type 1 and Type 2 pharmaceutical manufacturing and sales businesses.

9 Feb 2021Ministry of Health, Labour and Welfare
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Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices自主回収
Confirmed entity match

Trade name: Itraconazole Tablets 50 'MEEK'

4 Dec 2020Ministry of Health, Labour and Welfare
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医薬品医療機器等法自主回収
RepeatConfirmed entity match

Product name: Itraconazole Tablets 50 'MEEK'

4 Dec 2020Ministry of Health, Labour and Welfare
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医薬品医療機器等法自主回収
RepeatConfirmed entity match

福井県より、小林化工株式会社が下記の医薬品の自主回収に着手した旨の情報提供がなされました。

3 Oct 2019Ministry of Health, Labour and Welfare
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Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices自主回収
Confirmed entity match

Voluntary recall of pharmaceutical products

3 Oct 2019Ministry of Health, Labour and Welfare
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Language

日本語版を見る (Japanese)

Registry data

English name
小林化工株式会社
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
Status
Active

Note: This company may not have detailed gBizINFO data, or RegBase has not completed enrichment yet. The public sources below may contain supplemental registry information.

View on gBizINFO ↗View on National Tax Agency Corporate Number site ↗

gBizINFO: fetched 25 Apr 2026

Data sources

Breakdown by law

Breakdown by action type

About this English name

No official English name source is recorded. The original Japanese name is shown.

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小林化工株式会社 Japanese Enforcement Records and Compliance Profile | RegBase