Company
United StatesQuality Electrodynamics LLC, Mayfield Village, OH – FDA Inspections
Inspection records and compliance data for Quality Electrodynamics LLC in Mayfield Village, Ohio. 4 FDA inspections on record (1 OAI), 1 warning letter, last inspected September 16, 2016.
Company Profile
This profile covers Quality Electrodynamics LLC based in Mayfield Village, Ohio, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 1
First inspected March 5, 2009. Last inspected September 16, 2016.
Most cited issue areas
- Acceptance records1 inspection
- Documentation1 inspection
- Incoming inspection, testing, verification1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 16, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 985359 |
| March 9, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 915553 |
| July 27, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 736505 |
| March 5, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 566703 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Quality Electrodynamics LLC
FEI Number
3007350713
Address
6655 Beta Dr Ste 100, Mayfield Village, Ohio 44143, United States
Country
United States
ID: 0caffa60-b832-4ae3-9f5a-e6e102446804