FDA Inspection
Vygon MFG, Inc.Vygon MFG, Inc. – FDA Inspection, Feb 18, 2009
Record Details
This FDA Inspection record concerns Vygon MFG, Inc., with an inspection on February 18, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Vygon MFG, Inc.
- Inspection Date
- February 18, 2009
- Product Type
- Drugs
View Company Profile
ID · c58f3b8d-a5de-419c-a9fa-e4e511a1b743
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 577818
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 820.100(a)(5)Implementing changes
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.70(a)Process control procedures
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 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 |
Other documents for Vygon MFG, Inc.
- FDA Inspection 1054315 - 2018-05-21
- FDA Inspection 986397 - 2016-09-23
- FDA Inspection 848668 - 2013-09-05
- FDA Inspection 735332 - 2011-07-28
- FDA Inspection 702972 - 2010-12-17
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.