FDA Inspection
Polyganics Holding BVPolyganics Holding BV – FDA Inspection, Nov 21, 2019
Record Details
This FDA Inspection record concerns Polyganics Holding BV, with an inspection on November 21, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Polyganics Holding BV
- Inspection Date
- November 21, 2019
- Product Type
- Devices
View Company Profile
ID · 5f546182-96a7-494b-a177-59eff5b3eac3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1111641
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Polyganics Holding BV
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 6, 2015 | 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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