Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-05-04.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 May 2023 – 4 May 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Aug 2014 – 19 Aug 2014 | Medical Devices & Rad Health | 483 | On file |
| 1 Sep 2010 | Not recorded | Clean | |
| 4 Mar 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
4 May 2023
21 CFR 820.30(f)
Design verification - output does not meet input requirement
Cited by Michelle J Glembin, Gisselle I Sensebe
4 May 2023
21 CFR 820.30(f)
Design verification - output does not meet input requirement
Cited by Michelle J Glembin, Gisselle I Sensebe
4 May 2023
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Michelle J Glembin, Gisselle I Sensebe
Investigators
FDA investigators tied to this site in the record.
Michelle J Glembin1 insp.
Gisselle I Sensebe1 insp.
Melanie W Pishnery1 insp.
Melanie G Warzala1 insp.
Jason P Aun1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Suncoast Dental, Inc. dba Tatum Surgical's 2 Form 483s
Recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat