FDA Inspection
Neodontics IncNeodontics Inc – FDA Inspection, Jan 24, 2023
Record Details
This FDA Inspection record concerns Neodontics Inc, with an inspection on January 24, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 6296413c-7c4b-4917-87bd-23352ad45a91
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1195532
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.184(f)DHR - UDI not included
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Neodontics Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 17, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 10, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 28, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 26, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Neodontics Inc
- FDA Inspection 1115636 - 2020-01-17
- FDA Inspection 963088 - 2016-03-10
- FDA Inspection 846980 - 2013-08-28
- FDA Inspection 666542 - 2010-05-26
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