Company
United StatesStryker Communications, Flower Mound, TX – FDA Inspections
Inspection records and compliance data for Stryker Communications in Flower Mound, Texas. 6 FDA inspections on record, 1 Form 483, last inspected May 25, 2017.
Company Profile
This profile covers Stryker Communications based in Flower Mound, Texas, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 26, 2009. Last inspected May 25, 2017.
Most cited issue areas
- Individual Report of Malfunction1 inspection
- Supplier oversight1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 25, 2017 | Not classified | Medical Devices & Rad Health | 1029472 |
| March 3, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 964567 |
| November 13, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 806785 |
| March 2, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 770973 |
| July 20, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 596865 |
| January 26, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 556605 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Stryker Communications
FEI Number
3002975342
Address
571 Silveron Blvd, Flower Mound, Texas 75028, United States
Country
United States
ID: 4351086a-42f5-4846-9344-38f2d3e57984