Enforcement record
Business Improvement Order disclosure naming 沢井製薬株式会社九州工場
This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.
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
- Queued for preservation
- Captured: Jul 12, 2026, 03:35 PM JST
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Action summary
- Company
- 沢井製薬株式会社九州工場Japanese onlyOriginal: 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
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 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.
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.