Administrative Guidance 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
- Administrative Guidance行政指導
- Action date
- October 21, 2015
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
It was found that appropriate reports had not been made to the Ministry of Health, Labour and Welfare regarding discrepancies between the approval document and manufacturing practices. Consequently, on September 18, a request was made to suspend shipments and to submit proper reports. Subsequently, the Ministry of Health, Labour and Welfare reviewed the reported information.
Show original Japanese text
承認書と製造実態の齟齬等についての厚生労働省への報告が適切になされていないことが判明したことから、９月18日付けで出荷の自粛を要請するとともに適切な報告を求め、その後厚生労働省において報告内容の精査を行ってきました。
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
- 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.