Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-10-16.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Oct 2019 – 16 Oct 2019 | Biologics | Clean | |
| 31 Jan 2017 – 9 Feb 2017 | Biologics | 483 | View 483 → |
| 13 Jan 2015 – 17 Jan 2015 | Biologics | 483 | On file |
| 14 Jan 2015 – 16 Jan 2015 | Biologics | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Feb 2017
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Melissa D Kalik
Investigators
FDA investigators tied to this site in the record.
Melissa D Kalik3 insp.
Jennifer A Jones1 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 | 1x |
Full site report
Get the verbatim findings behind CSL Plasma, Inc.'s 3 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