FDA Inspection
Polyganics Holding BVPolyganics Holding BV – FDA Inspection, Aug 6, 2015
Record Details
This FDA Inspection record concerns Polyganics Holding BV, with an inspection on August 6, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Polyganics Holding BV
- Inspection Date
- August 6, 2015
- Product Type
- Devices
View Company Profile
ID · e6f07200-af96-4da3-8600-3e3db168d268
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 941277
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.184DHR content
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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 |
| June 18, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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