Kyowa Kirin Co., Ltd.
FDA inspection history in Takasaki-shi, Japan, 2018 to 2022
- 4
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2019: one Form 483; 2021: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–22Four Form 483s, at Takasaki-shi, Japan.
- 2022The longest 483 on file: 13 observations over 7 pages at Takasaki-shi, Japan.
Cited most
Across all Kyowa Kirin Co. observations on file
- 21 CFR 211.160General requirements5
- 21 CFR 211.192Production record review4
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.56Sanitation3
The complete Kyowa Kirin Co. 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
Takasaki-shi, Japan
Four Form 483s · 2018 to 2022 · 30 observations
Latest: Form 483, Dec 14, 2022 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-12-14 | 483 Form 483 | Takasaki-shi, Japan | 13 | $99 |
| 2021-08-30 | 483 Form 483 | Takasaki-shi, Japan | 7 | $99 |
| 2019-10-04 | 483 Form 483 | Takasaki-shi, Japan | 4 | $99 |
| 2018-12-11 | 483 Form 483 | Takasaki-shi, Japan | 6 | $99 |
Investigators on these documents
Chen Sun (1)Cynthia Jim (1)Dennis Cantellops (1)Jacek Cieslak (1)Madushini Dharmasena (1)Zhong Li (1)
FEI number 3007588904 · most recent document Dec 14, 2022
About Kyowa Kirin Co., Ltd.
How many FDA Form 483s has Kyowa Kirin Co., Ltd. received?
FDA Intel has 4 Form 483s on file for Kyowa Kirin Co., Ltd.; the most recent is dated Dec 14, 2022.
When was Kyowa Kirin Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Kyowa Kirin Co., Ltd. is a Form 483 dated Dec 14, 2022, for the site in Takasaki-shi, Japan.
What did FDA cite at Kyowa Kirin Co., Ltd.?
The regulations cited most in the observations on file for Kyowa Kirin Co., Ltd. are 21 CFR 211.160 (General requirements), 5 times; 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 4 times.