Kyowa Hakko Bio Co., Ltd.
FDA inspection history in Hofu, Japan, 2010 to 2019
- 2
- Warning letters
- 1
- Form 483
- 1
- Close-out
Every document, by year
- Form 483
- Warning letter
- Close-out
2010: one warning letter; 2012: one close-out letter; 2018: one warning letter; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2010–12One warning letter and one close-out letter, at Hofu, Japan.
- 2018–19One warning letter and one Form 483, at Hofu, Japan.
Cited most
Across all Kyowa Hakko Bio Co. observations on file
- 21 CFR 211.192Production record review1
The complete Kyowa Hakko Bio 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
Hofu, Japan
Two warning letters, one Form 483 and one close-out letter · 2010 to 2019 · 1 observation
Latest: Form 483, Nov 8, 2019 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-11-08 | 483 Form 483 | Hofu, Japan | 1 | $99 |
| 2018-08-10 | Warning letter Warning letter | Hofu, Japan | — | $99 |
| 2012-01-19 | Close-out Close-out letter | Hofu, Japan | — | $99 |
| 2010-09-29 | Warning letter Warning letter | Hofu, Japan | — | $99 |
FEI number 3002807424 · most recent document Nov 8, 2019
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 Nov 8, 2019.
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 Nov 8, 2019, for the site in Hofu, 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 211.192 (Production record review), 1 time.
Has Kyowa Hakko Bio Co., Ltd. received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Kyowa Hakko Bio Co., Ltd.; the most recent is dated Aug 10, 2018.