Overview
- 11 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-31.
At a glance
Inspections
11
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Jan 2025 – 31 Jan 2025 | Biologics | 483 | View 483 → |
| 27 Jun 2022 – 1 Jul 2022 | Biologics | 483 | View 483 → |
| 8 Jan 2018 – 12 Jan 2018 | Biologics | Clean | |
| 9 Feb 2016 – 12 Feb 2016 | Biologics | Clean | |
| 15 Sep 2014 – 17 Sep 2014 | Biologics | Clean | |
| 5 Apr 2012 | Not recorded | 483 | View 483 → |
| 10 Jun 2010 | Not recorded | Clean | |
| 15 Aug 2008 | Not recorded | 483 | On file |
| 13 May 2004 | Not recorded | Clean | |
| 10 May 2002 | Not recorded | Clean | |
| 10 Mar 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Jan 2025
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Barbara T Carmichael, Nerming V Briones, Steen N Graham
31 Jan 2025
21 CFR 606.100(c)
Thorough investigations
Cited by Barbara T Carmichael, Nerming V Briones, Steen N Graham
31 Jan 2025
21 CFR 606.171
Biological product deviation report
Cited by Barbara T Carmichael, Nerming V Briones, Steen N Graham
31 Jan 2025
21 CFR 606.20(b)
Qualifications of responsible personnel
Cited by Barbara T Carmichael, Nerming V Briones, Steen N Graham
1 Jul 2022
21 CFR 606.100(c)
Thorough investigations
Cited by Barbara T Carmichael, Lura D Baquero, Edward A Brunt
Investigators
FDA investigators tied to this site in the record.
Barbara T Carmichael2 insp.
Lura D Baquero2 insp.
Mizanne E Lewis2 insp.
Nerming V Briones1 insp.
Steen N Graham1 insp.
Edward A Brunt1 insp.
Samantha J Pinizzotto1 insp.
Nancy L Neiger1 insp.
Linda K Matheny1 insp.
Jana L Caylor1 insp.
Joan S Norton1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.171 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.40 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Suncoast Communities Blood Bank, Inc.'s 4 Form 483s
Source PDFs, verbatim observations, and 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