Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-07-28.
At a glance
Inspections
5
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Jul 2025 – 28 Jul 2025 | Biologics | Clean | |
| 8 Nov 2021 – 10 Nov 2021 | Biologics | Clean | |
| 23 Jul 2019 – 5 Aug 2019 | Biologics | 483 | View 483 → |
| 4 Jan 2017 | Biologics | Clean | |
| 5 May 2016 – 7 May 2016 | Biologics | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Aug 2019
21 CFR 606.171
Biological product deviation report
Cited by Nikisha M Bolden, Erika M Wilkerson
5 Aug 2019
21 CFR 630.10(c)
Donor Eligibility on day of donation
Cited by Nikisha M Bolden, Erika M Wilkerson
Investigators
FDA investigators tied to this site in the record.
Kish Bolden2 insp.
Nikisha M Bolden2 insp.
Erika M Wilkerson1 insp.
Bradley E Benasutti1 insp.
Judy E Ciaraldi1 insp.
Angel F Colon1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.171 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.10(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.10(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind CSL Plasma Inc.'s 1 Form 483
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