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
- September 1, 2021
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
It is believed that foreign matter contamination likely occurred during the manufacturing process. There have been reports, both domestically and internationally, of rare cases where rubber stopper-like fragments have been suspected to have mixed into vials, although the probability is very low. Even in such cases, it has been reported that the efficacy and safety of other vials from the same lot are unaffected. The foreign substance reported this time is considered to be a similar case.
Show original Japanese text
製造工程において異物混入が発生した可能性が高いと考えられる。これまでにも、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したと疑われる事例が国内外で報告されていること、その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ことが報告されており、今回報告された異物も同様の事例である可能性が高い。
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 武田薬品工業株式会社 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
- 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.