FDA Inspection
Suncoast Dental, Inc. dba Tatum SurgicalSuncoast Dental, Inc. dba Tatum Surgical – FDA Inspection, May 4, 2023
Record Details
This FDA Inspection record concerns Suncoast Dental, Inc. dba Tatum Surgical, with an inspection on May 4, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b7c6208b-ee6e-4cfc-b3d0-fe93051f91bb
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1204632
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Suncoast Dental, Inc. dba Tatum Surgical
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 19, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 1, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Suncoast Dental, Inc. dba Tatum Surgical
- FDA Inspection 891656 - 2014-08-19
- FDA Inspection 678500 - 2010-09-01
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