Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-08-14.
At a glance
Inspections
7
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Aug 2024 – 14 Aug 2024 | Biologics | 483 | View 483 → |
| 25 Apr 2022 – 29 Apr 2022 | Biologics | 483 | View 483 → |
| 9 Dec 2019 – 16 Dec 2019 | Biologics | 483 | View 483 → |
| 18 Jun 2018 – 21 Jun 2018 | Biologics | 483 | View 483 → |
| 14 Sep 2015 – 16 Sep 2015 | Biologics | Clean | |
| 20 Aug 2014 – 10 Sep 2014 | Biologics | 483 | On file |
| 10 Feb 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Aug 2024
21 CFR 606.100(c)
Record review prior to release
Cited by Kenneth L Smalls, Chanel E Crawford
14 Aug 2024
21 CFR 610.40(a)(2)
Test for HTLV, syphilis, West Nile, Chagas
Cited by Kenneth L Smalls, Chanel E Crawford
14 Aug 2024
21 CFR 630.15(b)(1)
Medical history and physical exam
Cited by Kenneth L Smalls, Chanel E Crawford
Investigators
FDA investigators tied to this site in the record.
Brandy Davis Brown3 insp.
Brentley S Collins2 insp.
Cordelia J Brammer2 insp.
Brandy D Brown2 insp.
Kenneth L Smalls1 insp.
Chanel E Crawford1 insp.
Marla A Cassidy1 insp.
Leslie W Gilbert1 insp.
Doretha M Tonkins1 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 | 3x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 630.15(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 630.40(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 630.5(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 610.40(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 630.40(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.121(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.121(c)(4)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.40(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.60(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 610.40(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.10(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.10(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.10(f)(3)(i)(B) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.10(g)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.10(g)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.10(h) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Specialty Blood Center's 6 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