FDA Inspection
Polyganics Holding BVPolyganics Holding BV – FDA Inspection, Jun 18, 2009
Record Details
This FDA Inspection record concerns Polyganics Holding BV, with an inspection on June 18, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Polyganics Holding BV
- Inspection Date
- June 18, 2009
- Product Type
- Devices
View Company Profile
ID · 6081ec3b-3cd6-4d05-8b9b-0c6738112afb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 594594
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.70(b)Verification or validation of changes
- 21 CFR 820.25(b)Training
- 21 CFR 820.90(a)Specific non-conforming product procedures
- 21 CFR 820.70(a)(1)Process control instructions
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Other FDA inspections of Polyganics Holding BV
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 6, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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