Company
JapanIntelligent System Co., Ltd., Nanto, Japan – FDA Inspections
Inspection records and compliance data for Intelligent System Co., Ltd. in Nanto. 2 FDA inspections on record, 2 Form 483s, last inspected May 18, 2023.
Company Profile
This profile covers Intelligent System Co., Ltd. based in Nanto, Japan.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected February 2, 2017. Last inspected May 18, 2023.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of procedures, or not maintained1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 18, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1206652 |
| February 2, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1007009 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Intelligent System Co., Ltd.
FEI Number
3009862126
Address
4316-1 Jec3f, Johana, Nanto, Japan
Country
Japan
ID: 944a900c-6614-431e-9386-f52a20e0bb69