Company
JapanOEM Systems Co. Ltd., Uji, Japan – FDA Inspections
Inspection records and compliance data for OEM Systems Co. Ltd. in Uji. 3 FDA inspections on record (1 OAI), last inspected January 27, 2023.
Company Profile
This profile covers OEM Systems Co. Ltd. based in Uji, Japan.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 0
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected October 28, 2010. Last inspected January 27, 2023.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- Design verification - Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 27, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1198268 |
| September 26, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 897530 |
| October 28, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 699130 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
OEM Systems Co. Ltd.
FEI Number
1000487132
Address
Megawa 84, Makishima-Cho, Uji, Japan
Country
Japan
ID: ae77cfad-7d58-4440-ad77-555abba2dfc2