Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-03-01.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Feb 2024 – 1 Mar 2024 | Biologics | Clean | |
| 22 May 2018 – 24 May 2018 | Biologics | 483 | View 483 → |
| 6 Aug 2015 – 10 Aug 2015 | Biologics | 483 | View 483 → |
| 19 Mar 2013 – 21 Mar 2013 | Biologics | Clean | |
| 18 Mar 2013 – 20 Mar 2013 | Biologics | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
24 May 2018
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Decarlos A Gomez
10 Aug 2015
21 CFR 606.100(a)
SOP compliance
Cited by Amanda J White, Monique S Frazier, Samuel J Arsenault
Investigators
FDA investigators tied to this site in the record.
Young M Yoon2 insp.
Michelle Paxon1 insp.
Decarlos A Gomez1 insp.
Amanda J White1 insp.
Monique S Frazier1 insp.
Samuel J Arsenault1 insp.
Judy E Ciaraldi1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(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 640.64(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Octapharma Plasma, Inc.'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