{"data":[{"id":"2ef899cd-84a5-469c-91e9-74c8b30c620d","company_name":"沢井製薬株式会社九州工場","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","law_name":"医薬品医療機器等法","action_type":"業務改善命令","action_date":"2023-12-22","announcement_date":"2026-04-02","violation_summary":"沢井製薬株式会社九州工場が製造する医薬品（テプレノンカプセル50mg「サワイ」）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。）が実施されていたことが確認されました。","violation_summary_en":"Sawai Pharmaceutical Co., Ltd. Kyushu Factory conducted quality tests on the pharmaceutical product Tepelonen Capsules 50mg 'Sawai' using a testing method different from that approved (replacing the drug into a different capsule before performing dissolution testing).","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/newpage_37021.html","url":"https://regbase.jp/enforcement/other-ze-jing-zhi-yao-jiu-zhou-gong-chang-20231222"}],"meta":{"query":"沢井製薬株式会社九州工場","corporate_number":null,"law":null,"authority":null,"action_type":null,"count":1,"api_docs":"https://regbase.jp/api-docs","openapi_schema":"https://regbase.jp/api/openapi.json","llms":"https://regbase.jp/llms.txt","usage_note":"Use RegBase for targeted public-source screening of Japanese companies and enforcement records. Absence of returned records is not a clearance, legal opinion, sanctions result, or credit decision.","rate_limit":{"limit":10,"window_seconds":60,"remaining":7,"reset_at":"2026-05-21T00:06:47.428Z"},"daily_rate_limit":{"limit":300,"window_seconds":86400,"remaining":23,"reset_at":"2026-05-22T00:05:47.428Z"}}}