Company
JapanSakura Seiki Co., Ltd. Chikuma Factory, Chikuma, Japan – FDA Inspections
Inspection records and compliance data for Sakura Seiki Co., Ltd. Chikuma Factory in Chikuma, -. 3 FDA inspections on record, 3 Form 483s, last inspected March 05, 2026.
Company Profile
This profile covers Sakura Seiki Co., Ltd. Chikuma Factory based in Chikuma, Japan.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 3
- Warning letters
- 0
First inspected February 15, 2019. Last inspected March 5, 2026.
Most cited issue areas
- DHR - not or inadequately maintained1 inspection
- Lack of System for Determining MDR Events1 inspection
- Management review - defined interval, sufficient frequency1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 5, 2026 | Not classified | Medical Devices & Rad Health | 1311276 |
| March 24, 2023 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1200617 |
| February 15, 2019 | Not classified | Medical Devices & Rad Health | 1085815 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Sakura Seiki Co., Ltd. Chikuma Factory
FEI Number
3009685834
Address
46-1, Oazashinden, Chikuma, - -, Japan
Country
Japan
ID: f9b79c21-3fd4-4ff7-bdd8-a97c13aa71e2