FDA Inspection
Neodontics IncNeodontics Inc – FDA Inspection, Aug 28, 2013
Record Details
This FDA Inspection record concerns Neodontics Inc, with an inspection on August 28, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Neodontics Inc
- Inspection Date
- August 28, 2013
- Product Type
- Devices
View Company Profile
ID · f31fa0f7-c235-4d0c-a097-d998c691a2cd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 846980
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.184DHR content
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Neodontics Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 24, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 |
| May 26, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Neodontics Inc
- FDA Inspection 1195532 - 2023-01-24
- FDA Inspection 1115636 - 2020-01-17
- FDA Inspection 963088 - 2016-03-10
- FDA Inspection 666542 - 2010-05-26
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