Company
BelgiumDENTSPLY Implants N.V., Hasselt, Belgium – FDA Inspections
Inspection records and compliance data for DENTSPLY Implants N.V. in Hasselt. 1 FDA inspection on record, 1 Form 483, last inspected August 31, 2017.
Company Profile
This profile covers DENTSPLY Implants N.V. based in Hasselt, Belgium.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected August 31, 2017.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Software validation for automated processes1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 31, 2017 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1024009 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
DENTSPLY Implants N.V.
FEI Number
3007362683
Address
Research Campus 10, Hasselt, Belgium
Country
Belgium
ID: 63e3f36d-8806-40aa-b9d6-c35cbaf6a2d7