Overview
- 9 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-13.
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 |
|---|---|---|---|
| 12 Jun 2025 – 13 Jun 2025 | Biologics | Clean | |
| 20 Apr 2022 – 22 Apr 2022 | Biologics | 483 | View 483 → |
| 15 Nov 2016 – 21 Nov 2016 | Biologics | 483 | On file |
| 3 Nov 2014 – 4 Nov 2014 | Biologics | Clean | |
| 15 Nov 2012 | Not recorded | Clean | |
| 2 Dec 2010 | Not recorded | Clean | |
| 24 Apr 2008 | Not recorded | 483 | On file |
| 18 Jul 2005 | Not recorded | Clean | |
| 21 Aug 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Apr 2022
21 CFR 630.10(e)(2)
Additional Medical Assessment Factors
Cited by Richard T Riggie, Bobbi J Miller
22 Apr 2022
21 CFR 630.10(e)(2)
Additional Medical Assessment Factors
Cited by Richard T Riggie, Bobbi J Miller
22 Apr 2022
21 CFR 630.10(e)(2)
Additional Medical Assessment Factors
Cited by Richard T Riggie, Bobbi J Miller
Investigators
FDA investigators tied to this site in the record.
Merelynn Rhoten2 insp.
Michelle D Gutierrez1 insp.
Richard T Riggie1 insp.
Bobbi J Miller1 insp.
Young M Yoon1 insp.
Judy E Ciaraldi1 insp.
Hoimay Chan1 insp.
Deniza Karacic1 insp.
Darla J Christopher1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 630.10(e)(2) | Cited across public-safe Form 483 observations | 3x |
Full site report
Get the verbatim findings behind Kedplasma LLC's 3 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