Company
United StatesStradis Medical, LLC dba Stradis Healthcare, Peachtree Corners, GA – FDA Inspections
Inspection records and compliance data for Stradis Medical, LLC dba Stradis Healthcare in Peachtree Corners, Georgia. 6 FDA inspections on record (1 OAI), last inspected August 05, 2021.
Company Profile
This profile covers Stradis Medical, LLC dba Stradis Healthcare based in Peachtree Corners, Georgia, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 3
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected April 3, 2009. Last inspected August 5, 2021.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- Documentation of validated process performance1 inspection
- General1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 5, 2021 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1148060 |
| December 19, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 996163 |
| March 26, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 883715 |
| February 29, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 770839 |
| April 12, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 719657 |
| April 3, 2009 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 593499 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Stradis Medical, LLC dba Stradis Healthcare
FEI Number
1000111025
Address
3025 Northwoods Pkwy, Peachtree Corners, Georgia 30071, United States
Country
United States
ID: d3fa8f7e-8afa-4e56-80b5-e674b71a637a