Company
JapanTerumo Corporation Fujinomiya Factory, Fujinomiya, Japan – FDA Inspections
Inspection records and compliance data for Terumo Corporation Fujinomiya Factory in Fujinomiya. 4 FDA inspections on record, 2 Form 483s, last inspected May 19, 2023.
Company Profile
This profile covers Terumo Corporation Fujinomiya Factory based in Fujinomiya, Japan.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected September 16, 2011. Last inspected May 19, 2023.
Most cited issue areas
- Backup file not maintained1 inspection
- Complete Test Data1 inspection
- Procedures for sterile drug products1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 19, 2023 | Not classified | Biologics | 1206261 |
| February 7, 2017 | VAI | Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 1004817 |
| March 20, 2014 | VAI | Human Drugs · Drug Quality Assurance | 875358 |
| September 16, 2011 | VAI | Human Drugs · Drug Quality Assurance | 746978 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Terumo Corporation Fujinomiya Factory
FEI Number
3002808337
Address
818, Misonodaira, Fujinomiya, Japan
Country
Japan
ID: 82a74871-bc83-43dc-b1cc-7ae24148d80f