Company
United StatesMedical Device Resource Corporation, Livermore, CA – FDA Inspections
Inspection records and compliance data for Medical Device Resource Corporation in Livermore, California. 4 FDA inspections on record (2 OAI), 2 warning letters, last inspected February 16, 2018.
Company Profile
This profile covers Medical Device Resource Corporation based in Livermore, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 2
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 2
First inspected April 9, 2012. Last inspected February 16, 2018.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures2 inspections
- Design output - Lack of or inadequate procedures2 inspections
- DMR - not or inadequately maintained2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 16, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1044567 |
| July 14, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 887300 |
| May 6, 2013 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 830915 |
| April 9, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 776342 |
FDA documents
Warning Letters (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Medical Device Resource Corporation
FEI Number
1000161191
Address
5981 Graham Ct, Livermore, California 94550, United States
Country
United States
ID: 388c9879-1df2-408a-86a8-53738ae5b978