FDA Inspection
DENTSPLY Implants (a Division of DENTSPLY IH AB)DENTSPLY Implants (a Division of DENTSPLY IH AB) – FDA Inspection, Sep 3, 2009
Record Details
This FDA Inspection record concerns DENTSPLY Implants (a Division of DENTSPLY IH AB), with an inspection on September 3, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 3, 2009
- Product Type
- Devices
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ID · c2da0aed-5902-4064-9e27-ccd9235cb592
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 613120
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of DENTSPLY Implants (a Division of DENTSPLY IH AB)
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 21, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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