FDA Inspection
American Dental Implant CorporationAmerican Dental Implant Corporation – FDA Inspection, Jul 26, 2017
Record Details
This FDA Inspection record concerns American Dental Implant Corporation, with an inspection on July 26, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 2c2b221c-7915-4ead-bd47-d26f7fae255a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1020611
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of American Dental Implant Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 23, 2025 | NAI | Compliance: Devices | |
| April 10, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 4, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for American Dental Implant Corporation
- FDA Inspection 1294374 - 2025-10-23
- FDA Inspection 826904 - 2013-04-10
- FDA Inspection 695914 - 2010-11-04
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