Company
United StatesElectro-Diagnostic Imaging, Inc., Milpitas, CA – FDA Inspections
Inspection records and compliance data for Electro-Diagnostic Imaging, Inc. in Milpitas, California. 4 FDA inspections on record, 1 Form 483, last inspected May 26, 2017.
Company Profile
This profile covers Electro-Diagnostic Imaging, Inc. based in Milpitas, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 22, 2010. Last inspected May 26, 2017.
Most cited issue areas
- Design history file1 inspection
- Design input - documentation1 inspection
- Design output - documentation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 26, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1011975 |
| June 26, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 837440 |
| November 3, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 752868 |
| February 22, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 651866 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Electro-Diagnostic Imaging, Inc.
FEI Number
3002900377
Address
1551 Mccarthy Blvd Ste 114, Milpitas, California 95035, United States
Country
United States
ID: c0cca738-147f-415b-bf6f-2e9dba9cf5b7