Administrative Guidance against 小林化工株式会社
Action summary
- Company
- 小林化工株式会社Japanese onlyOriginal: 小林化工株式会社Corporate Number: 6210001007109
- Governing law
- Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices薬機法
- Action type
- Administrative Guidance行政指導
- Action date
- April 16, 2021
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
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.
Show original Japanese text
承認申請用の安定性試験について、安定性試験の実施日、分析法バリデーションの実施日等を改ざんしていた。承認申請書の記載とは異なる方法で製造された製剤で、承認申請用の安定性試験を行っていた。
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)Company info
- English name
- 小林化工株式会社 Japanese only
- 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
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.