Eisai, Inc.
FDA inspection history in Kakamigahara, Japan, 2018 to 2023
- 4
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2019: one Form 483; 2022: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–19Two Form 483s, at Kakamigahara, Japan.
- 2018The longest 483 on file: 7 observations over 4 pages at Kakamigahara, Japan.
- 2022–23Two Form 483s, at Kakamigahara, Japan.
Cited most
Across all Eisai observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 211.67(a)Equipment cleaning and maintenance2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.111Time limitations on production1
The complete Eisai file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Kakamigahara, Japan
Four Form 483s · 2018 to 2023 · 12 observations
Latest: Form 483, Oct 27, 2023 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-10-27 | 483 Form 483 | Kakamigahara, Japan | 2 | $99 |
| 2022-11-02 | 483 Form 483 | Kakamigahara, Japan | 1 | $99 |
| 2019-06-28 | 483 Form 483 | Kakamigahara, Japan | 2 | $99 |
| 2018-12-21 | 483 Form 483 | Kakamigahara, Japan | 7 | $99 |
Investigators on these documents
FEI number 3004967045 · most recent document Oct 27, 2023
About Eisai, Inc.
How many FDA Form 483s has Eisai, Inc. received?
FDA Intel has 4 Form 483s on file for Eisai, Inc.; the most recent is dated Oct 27, 2023.
When was Eisai, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Eisai, Inc. is a Form 483 dated Oct 27, 2023, for the site in Kakamigahara, Japan.
What did FDA cite at Eisai, Inc.?
The regulations cited most in the observations on file for Eisai, Inc. are 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.67(a) (Equipment cleaning and maintenance), 2 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 2 times.