Company
United StatesElwyn Inc, Aston, PA – FDA Inspections
Inspection records and compliance data for Elwyn Inc in Aston, Pennsylvania. 4 FDA inspections on record, 1 Form 483, last inspected November 21, 2017.
Company Profile
This profile covers Elwyn Inc based in Aston, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 4
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected November 12, 2008. Last inspected November 21, 2017.
Most cited issue areas
- Equipment control activity documentation1 inspection
- General1 inspection
- Investigation procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 21, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1032372 |
| April 27, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 662987 |
| January 28, 2009 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 558169 |
| November 12, 2008 | VAI | Medical Devices & Rad Health · Compliance: Devices | 547557 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Elwyn Inc
FEI Number
2522836
Address
1 Judy Way, Aston, Pennsylvania 19014, United States
Country
United States
ID: 808c8d38-407c-4133-b08e-fce9ac715a3d