Administrative Guidance against 武田薬品工業株式会社
Action summary
- Company
- 武田薬品工業株式会社Japanese onlyOriginal: 武田薬品工業株式会社Corporate Number: 2120001077461
- 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
- August 29, 2021
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
During the manufacturing process, although the probability is very low, there is a rare possibility that fragments resembling rubber stoppers could be mixed into the vials. Even if rubber stopper fragments are mixed in, it has been reported that there are no issues with the efficacy or safety of other vials from the same lot.
Show original Japanese text
製造工程において、確率は非常に低いものの、ごくまれに製品のゴム栓様の破片がバイアル内に混入する可能性があり、万が一、ゴム栓破片が混入した場合でも、同一ロットの他のバイアルの有効性及び安全性に問題はないと報告されている。
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
- 武田薬品工業株式会社 Japanese only
- Japanese name
- 武田薬品工業株式会社
- Corporate Number
- 2120001077461
- Registered address
- 大阪府大阪市中央区道修町４丁目１番１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.