FDA Inspection
Vygon MFG, Inc.Vygon MFG, Inc. – FDA Inspection, Sep 23, 2016
Record Details
This FDA Inspection record concerns Vygon MFG, Inc., with an inspection on September 23, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Vygon MFG, Inc.
- Inspection Date
- September 23, 2016
- Product Type
- Devices
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ID · b7b1eaac-6bb7-4928-83fb-e8cb72fa3a35
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 986397
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Vygon MFG, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 21, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 1054315 - 2018-05-21
- 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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