Company
JapanOtsuka Pharmaceutical Co., Ltd., Kanzaki-Gun, Japan – FDA Inspections
Inspection records and compliance data for Otsuka Pharmaceutical Co., Ltd. in Kanzaki-Gun. 6 FDA inspections on record, 2 Form 483s, last inspected July 11, 2025.
Company Profile
This profile covers Otsuka Pharmaceutical Co., Ltd. based in Kanzaki-Gun, Japan.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 5
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected October 14, 2011. Last inspected July 11, 2025.
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 11, 2025 | Not classified | Human Drugs | 1279569 |
| February 1, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1082945 |
| April 8, 2016 | VAI | Human Drugs · Drug Quality Assurance | 969045 |
| December 5, 2014 | VAI | Human Drugs · Drug Quality Assurance | 908834 |
| July 25, 2012 | VAI | Human Drugs · Drug Quality Assurance | 795311 |
| October 14, 2011 | VAI | Human Drugs · Drug Quality Assurance | 749028 |
FDA documents
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Company Information
Name
Otsuka Pharmaceutical Co., Ltd.
FEI Number
3003808559
Address
5006-5 Azahigashiyama, Omagari; Yoshinogari-Cho, Kanzaki-Gun, Japan
Country
Japan
ID: c050e25d-d3f2-41d0-a3e6-cd706dc4c417