Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-11-10.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Nov 2022 – 10 Nov 2022 | Biologics | 483 | View 483 → |
| 9 Sep 2019 – 12 Sep 2019 | Biologics | Clean | |
| 31 Aug 2015 – 1 Sep 2015 | Biologics | Clean | |
| 3 Aug 2012 | Not recorded | Clean | |
| 2 Apr 2010 | Not recorded | 483 | On file |
| 26 Aug 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Nisha C Patel1 insp.
Jason D Abel1 insp.
Mizanne E Lewis1 insp.
Valerie J Grecek Trinh1 insp.
Barbara T Carmichael1 insp.
Ronnie E Jackson1 insp.
Courtney A Gilbert1 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 |
Full site report
Get the verbatim findings behind KEDPlasma, LLC's 2 Form 483s
Source PDFs 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