Company
United StatesSuncoast Dental, Inc. dba Tatum Surgical, Clearwater, FL – FDA Inspections
Inspection records and compliance data for Suncoast Dental, Inc. dba Tatum Surgical in Clearwater, Florida. 3 FDA inspections on record, 1 Form 483, last inspected May 04, 2023.
Company Profile
This profile covers Suncoast Dental, Inc. dba Tatum Surgical based in Clearwater, Florida, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected September 1, 2010. Last inspected May 4, 2023.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Design verification - output does not meet input requirement1 inspection
- Documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 4, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1204632 |
| August 19, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 891656 |
| September 1, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 678500 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Suncoast Dental, Inc. dba Tatum Surgical
FEI Number
1000114355
Address
4500 140th Ave N Ste 112, Clearwater, Florida 33762, United States
Country
United States
ID: b8d993ec-eda1-49ed-a52b-670fff394542