Company
United StatesVygon MFG, Inc., Dover, NH – FDA Inspections
Inspection records and compliance data for Vygon MFG, Inc. in Dover, New Hampshire. 6 FDA inspections on record, 1 Form 483, last inspected May 21, 2018.
Company Profile
This profile covers Vygon MFG, Inc. based in Dover, New Hampshire, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 3
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected February 18, 2009. Last inspected May 21, 2018.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Implementing changes1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 21, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1054315 |
| September 23, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 986397 |
| September 5, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 848668 |
| July 28, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 735332 |
| December 17, 2010 | VAI | Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 702972 |
| February 18, 2009 | VAI | Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 577818 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Vygon MFG, Inc.
FEI Number
1000120555
Address
87 Venture Dr, Dover, New Hampshire 03820, United States
Country
United States
ID: 609245ef-6ebb-4020-8ef6-43be921cb444