Overview
- 9 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-06-20.
At a glance
Inspections
9
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Jun 2024 – 20 Jun 2024 | Biologics | Clean | |
| 24 Feb 2020 – 4 Mar 2020 | Biologics | 483 | View 483 → |
| 9 Mar 2017 – 10 Mar 2017 | Biologics | Clean | |
| 26 Aug 2015 – 27 Aug 2015 | Biologics | Clean | |
| 15 Jul 2013 – 18 Jul 2013 | Biologics | Clean | |
| 1 Jun 2012 | Not recorded | Clean | |
| 16 Aug 2011 | Not recorded | 483 | View 483 → |
| 14 Oct 2009 | Not recorded | 483 | View 483 → |
| 29 Jun 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Aug 2011
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Sarah A Palmer
14 Oct 2009
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Melissa J Holz
Investigators
FDA investigators tied to this site in the record.
Sarah A Palmer4 insp.
Ismael Olvera-Iv1 insp.
Elizabeth B Griffin1 insp.
Susan M Miller1 insp.
Jesse P Romenesko1 insp.
Melissa J Holz1 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 600.14(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.40(b)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind The Community Blood Center, Inc.'s 3 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