Company
NetherlandsPolyganics Holding BV, Groningen, Netherlands – FDA Inspections
Inspection records and compliance data for Polyganics Holding BV in Groningen. 3 FDA inspections on record, last inspected November 21, 2019.
Company Profile
This profile covers Polyganics Holding BV based in Groningen, Netherlands.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected June 18, 2009. Last inspected November 21, 2019.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design input - documentation1 inspection
- DHR content1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 21, 2019 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1111641 |
| August 6, 2015 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 941277 |
| June 18, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 594594 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Polyganics Holding BV
FEI Number
3004504732
Address
Rozenburglaan 15A, Groningen, Netherlands
Country
Netherlands
ID: 9b227bf2-01b8-4742-84bb-ea375580fe14