Company
JapanKyowa Hakko Bio Co. Ltd., Ube, Japan – FDA Inspections
Inspection records and compliance data for Kyowa Hakko Bio Co. Ltd. in Ube. 4 FDA inspections on record, 1 Form 483, last inspected November 08, 2019.
Company Profile
This profile covers Kyowa Hakko Bio Co. Ltd. based in Ube, Japan.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected July 2, 2010. Last inspected November 8, 2019.
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 8, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1113169 |
| September 15, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1026240 |
| March 14, 2014 | VAI | Human Drugs · Drug Quality Assurance | 873176 |
| July 2, 2010 | VAI | Human Drugs · Drug Quality Assurance | 675346 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Kyowa Hakko Bio Co. Ltd.
FEI Number
3002807425
Address
2548, Fujimagari, Ube, Japan
Country
Japan
ID: 09d5ed98-2ceb-4216-8fc1-51327eb2f42a