Overview
- 8 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-01-11.
At a glance
Inspections
8
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Jan 2024 – 11 Jan 2024 | Biologics | Clean | |
| 4 Apr 2019 – 5 Apr 2019 | Biologics | Clean | |
| 31 Jul 2017 – 2 Aug 2017 | Biologics | Clean | |
| 27 Feb 2014 – 17 Mar 2014 | Biologics | 483 | View 483 → |
| 5 Apr 2012 | Not recorded | Clean | |
| 15 Oct 2009 | Not recorded | 483 | View 483 → |
| 15 May 2008 | Not recorded | Clean | |
| 22 Jun 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Mar 2014
21 CFR 606.100(b)(12)
Criteria for suitability of reissue of returned blood
Cited by Diana L Ayala
Investigators
FDA investigators tied to this site in the record.
Maira P Brading4 insp.
Ramon L Gonzalez-Prieto1 insp.
Abby L Mozeke-Baker1 insp.
Erika M Wilkerson1 insp.
Diana L Ayala1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 600.10(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.11(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.40(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.60(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.3(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Carter BloodCare's 2 Form 483s
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