Business Improvement Order against 沢井製薬株式会社九州工場
沢井製薬株式会社九州工場 (医薬品医療機器等法)
医薬品医療機器等法Ministry of Health, Labour and WelfareDecember 22, 2023
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
- 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
- December 22, 2023
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Machine-translated summary — verify against original
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。
Source
Original Ministry of Health, Labour and Welfare announcement (in Japanese)The original Japanese disclosure is the authoritative record.
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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.