Kyowa Hakko Bio Co., Ltd.
FDA inspection history in Hofu-city, Japan, 2022
- 1
- Form 483
Every document, by year
- Form 483
2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Hofu-city, Japan.
Cited most
Across all Kyowa Hakko Bio Co. observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Kyowa Hakko Bio Co. file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Hofu-city, Japan
One Form 483 · 2022 · 5 observations
Latest: Form 483, Apr 15, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-04-15 | 483 Form 483 | Hofu-city, Japan | 5 | $99 |
Investigators on these documents
FEI number 3002807 · most recent document Apr 15, 2022
About Kyowa Hakko Bio Co., Ltd.
How many FDA Form 483s has Kyowa Hakko Bio Co., Ltd. received?
FDA Intel has 1 Form 483 on file for Kyowa Hakko Bio Co., Ltd.; the most recent is dated Apr 15, 2022.
When was Kyowa Hakko Bio Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Kyowa Hakko Bio Co., Ltd. is a Form 483 dated Apr 15, 2022, for the site in Hofu-city, Japan.
What did FDA cite at Kyowa Hakko Bio Co., Ltd.?
The regulations cited most in the observations on file for Kyowa Hakko Bio Co., Ltd. are 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.