Company
SwedenDENTSPLY Implants (a Division of DENTSPLY IH AB), Molndal, Sweden – FDA Inspections
Inspection records and compliance data for DENTSPLY Implants (a Division of DENTSPLY IH AB) in Molndal. 2 FDA inspections on record, last inspected February 21, 2013.
Company Profile
This profile covers DENTSPLY Implants (a Division of DENTSPLY IH AB) based in Molndal, Sweden.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected September 3, 2009. Last inspected February 21, 2013.
Most cited issue areas
- Environmental control Lack of or inadequate procedures1 inspection
- Nonconforming product control1 inspection
- Process control procedures, Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 21, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 824857 |
| September 3, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 613120 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
DENTSPLY Implants (a Division of DENTSPLY IH AB)
FEI Number
3002806429
Address
Aminogatan 1, Molndal, Sweden
Country
Sweden
ID: 0c54aa33-a94a-4f32-b3f3-c58853d70520