Company
United StatesEDM3 LLC, Jacksonville, FL – FDA Inspections
Inspection records and compliance data for EDM3 LLC in Jacksonville, Florida. 3 FDA inspections on record, 1 Form 483, last inspected June 30, 2017.
Company Profile
This profile covers EDM3 LLC based in Jacksonville, Florida, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected February 6, 2012. Last inspected June 30, 2017.
Most cited issue areas
- DHR content1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of System for Event Evaluations1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 30, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1016612 |
| May 12, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 879443 |
| February 6, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 767068 |
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
EDM3 LLC
FEI Number
1000526105
Address
3611 Saint Johns Bluff Rd S Ste 1, Jacksonville, Florida 32224, United States
Country
United States
ID: ab044c7c-bca0-4398-a96c-c0f4e3584233