FDA Inspection
Vygon MFG, Inc.Vygon MFG, Inc. – FDA Inspection, May 21, 2018
Record Details
This FDA Inspection record concerns Vygon MFG, Inc., with an inspection on May 21, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Abby E. Pelletier (Issuing Officer)
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ID · 588d3aaa-53c1-4b58-82bb-1a9e57e4de14
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1054315
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Vygon MFG, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 23, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 5, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 28, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 17, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 18, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Vygon MFG, Inc.
- FDA Inspection 986397 - 2016-09-23
- FDA Inspection 848668 - 2013-09-05
- FDA Inspection 735332 - 2011-07-28
- FDA Inspection 702972 - 2010-12-17
- FDA Inspection 577818 - 2009-02-18
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