Directive against 一般財団法人化学及血清療法研究所
Action summary
- Company
- 一般財団法人化学及血清療法研究所Japanese onlyOriginal: 一般財団法人化学及血清療法研究所Corporate Number: 6330005006672
- Governing law
- Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices薬機法
- Action type
- Directive指示
- Action date
- June 5, 2015
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
It was found that the product was manufactured using a method different from the approved method. - Heparin was added without being listed in the approval document. - Additives were used in quantities different from those specified in the approval document. - Some steps in the manufacturing process described in the approval document were modified or omitted.
Show original Japanese text
承認書と異なる製造方法により製造されていることが判明しました。・ 承認書に記載していないヘパリンを添加。・ 承認書に記載された量と異なる添加剤を使用。・ 承認書に記載された工程を一部改変・省略。
Source
Original Ministry of Health, Labour and Welfare announcement (in Japanese)The original Japanese disclosure is the authoritative record.
Watch this company
Get an email when 一般財団法人化学及血清療法研究所 has new enforcement actions or registry changes (representative, address, business status). Sign-in is via a one-time email link — no password.
Language
日本語版を見る (Japanese)Company info
- English name
- 一般財団法人化学及血清療法研究所 Japanese only
- Japanese name
- 一般財団法人化学及血清療法研究所
- Corporate Number
- 6330005006672
- Registered address
- 熊本県熊本市中央区新市街８番７号
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.