{"data":[{"id":"cb14635f-4a34-4079-95e4-5cbaa201fa9d","company_name":"フェリング・ファーマ株式会社","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":"2023-04-28","announcement_date":"2026-04-02","violation_summary":"医薬品（ＨＭＧ注射用７５ＩＵ「フェリング」及びＨＭＧ注射用１５０ＩＵ「フェリング」）について、その原薬の製造業者（Instituto Massone S.A.（アルゼンチン））に対して、令和４年11月に独立行政法人医薬品医療機器総合機構が実地調査を行った結果、｢医薬品及び医薬部外品の製造管理及び品質管理の基準｣（ＧＭＰ省令）に適合しないことが確認された。","violation_summary_en":"Regarding pharmaceuticals (HMG Injection 75 IU 'Ferring' and HMG Injection 150 IU 'Ferring'), the Pharmaceuticals and Medical Devices Agency conducted an on-site inspection of the active pharmaceutical ingredient manufacturer, Instituto Massone S.A. (Argentina), in November 2022. It was confirmed that the manufacturer did not comply with the standards for manufacturing and quality control of pharmaceuticals and quasi-drugs (GMP Ordinance).","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":85,"method":"nta_strict_name_nationally_unique","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/newpage_32898.html","url":"https://regbase.jp/enforcement/other-hueringuhuama-20230428"}],"meta":{"query":"フェリング・ファーマ株式会社","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":6,"reset_at":"2026-07-28T15:27:51.868Z"},"daily_rate_limit":{"limit":300,"window_seconds":86400,"remaining":87,"reset_at":"2026-07-29T15:26:51.868Z"}}}