Company
United StatesMedgyn Products, Inc., Westmont, IL – FDA Inspections
Inspection records and compliance data for Medgyn Products, Inc. in Westmont, Illinois. 3 FDA inspections on record, 1 Form 483, last inspected January 18, 2018.
Company Profile
This profile covers Medgyn Products, Inc. based in Westmont, Illinois, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 6, 2012. Last inspected January 18, 2018.
Most cited issue areas
- Analyzing service report1 inspection
- Design history file1 inspection
- Design validation - production units1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 18, 2018 | Not classified | Medical Devices & Rad Health | 1055239 |
| October 15, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 903913 |
| September 6, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 797536 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Medgyn Products, Inc.
FEI Number
1450908
Address
800 Pasquinelli Dr, Westmont, Illinois 60559-1275, United States
Country
United States
ID: 6a0e2271-24ca-4b71-872d-21bdaf40c19f