Company
United StatesImorgon Medical LLC, San Mateo, CA – FDA Inspections
Inspection records and compliance data for Imorgon Medical LLC in San Mateo, California. 3 FDA inspections on record, last inspected February 05, 2019.
Company Profile
This profile covers Imorgon Medical LLC based in San Mateo, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected August 31, 2011. Last inspected February 5, 2019.
Most cited issue areas
- Design validation - software validation not performed1 inspection
- Justification for not reporting1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 5, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1080784 |
| October 29, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 901731 |
| August 31, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 741564 |
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
Imorgon Medical LLC
FEI Number
3007208280
Address
1700 S El Camino Real Ste 335, San Mateo, California 94402, United States
Country
United States
ID: 3631cfcf-2049-4302-9193-d139b57b6b3a