Company
JapanOhta's Isan Co., Ltd., Ushiku, Japan – FDA Inspections
Inspection records and compliance data for Ohta's Isan Co., Ltd. in Ushiku. 3 FDA inspections on record, 1 Form 483, last inspected October 27, 2023.
Company Profile
This profile covers Ohta's Isan Co., Ltd. based in Ushiku, Japan.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 1, 2012. Last inspected October 27, 2023.
Most cited issue areas
- Component identity verification1 inspection
- Lab controls established, including changes1 inspection
- Written sanitation procedures lacking1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 27, 2023 | NAI | Human Drugs · Drug Quality Assurance | 1225352 |
| October 28, 2016 | VAI | Human Drugs · Drug Quality Assurance | 993138 |
| November 1, 2012 | VAI | Human Drugs · Drug Quality Assurance | 811423 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Ohta's Isan Co., Ltd.
FEI Number
1000424979
Address
957, Shishiko-Cho, Ushiku, Japan
Country
Japan
ID: 271f3b25-1f01-474b-9b62-cf15aafa1b6b