FDA Inspection
Planet DDSPlanet DDS – FDA Inspection, Dec 3, 2010
Record Details
This FDA Inspection record concerns Planet DDS, with an inspection on December 3, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Planet DDS
- Inspection Date
- December 3, 2010
- Product Type
- Devices
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ID · c5de3f8d-571d-49f3-ba8a-dc3159e6480c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 699520
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.30(g)Design validation - software validation documentation
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Planet DDS
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 23, 2018 | Not classified | Cincinnati District Office | |
| November 18, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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