Takeda Pharmaceutical Company Limited
FDA inspection history in Hikari, Japan, 2019 to 2023
- 3
- Form 483s
- 2
- Close-outs
Every document, by year
- Form 483
- Close-out
2019: one Form 483; 2020: one close-out letter; 2021: one close-out letter; 2023: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–23Three Form 483s and two close-out letters, at Hikari, Japan.
- 2019The longest 483 on file: 7 observations over 7 pages at Hikari, Japan.
Cited most
Across all Takeda Pharmaceutical Company Limited observations on file
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.192Production record review2
- 21 CFR 211.165(f)Testing and release for distribution1
The complete Takeda Pharmaceutical Company Limited file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Hikari, Japan
Three Form 483s and one close-out letter · 2019 to 2023 · 14 observations
Latest: Form 483, Nov 6, 2023 →
Also: one document not tied to a site.
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-11-06 | 483 Form 483 | Hikari, Japan | — | $99 |
| 2023-05-24 | 483 Form 483 | Hikari, Japan | 7 | $99 |
| 2021-10-13 | Close-out Close-out letter | — | — | $99 |
| 2020-06-09 | Close-out Close-out letter | Hikari, Japan | — | $99 |
| 2019-11-26 | 483 Form 483 | Hikari, Japan | 7 | $99 |
Investigators on these documents
Burnell M. Henry (1)Ileana Barreto-Pettit (1)Roger F. Zabinski (1)Steven M. Weinman (1)
FEI number 3004664162 · most recent document Nov 6, 2023
About Takeda Pharmaceutical Company Limited
How many FDA Form 483s has Takeda Pharmaceutical Company Limited received?
FDA Intel has 3 Form 483s on file for Takeda Pharmaceutical Company Limited; the most recent is dated Nov 6, 2023.
When was Takeda Pharmaceutical Company Limited last inspected by FDA?
The most recent FDA inspection document on file for Takeda Pharmaceutical Company Limited is a Form 483 dated Nov 6, 2023, for the site in Hikari, Japan.
What did FDA cite at Takeda Pharmaceutical Company Limited?
The regulations cited most in the observations on file for Takeda Pharmaceutical Company Limited are 21 CFR 211.22 (Responsibilities of quality control unit), 4 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times.