Overview
- 9 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-15.
At a glance
Inspections
9
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 May 2026 – 15 May 2026 | Biologics | Clean | |
| 22 Sep 2021 – 23 Sep 2021 | Biologics | Clean | |
| 14 Mar 2017 – 16 Mar 2017 | Biologics | Clean | |
| 3 Mar 2015 – 5 Mar 2015 | Biologics | Clean | |
| 8 Jan 2013 | Not recorded | Clean | |
| 15 Dec 2011 | Not recorded | Clean | |
| 3 Mar 2010 | Not recorded | Clean | |
| 29 May 2009 | Not recorded | 483 | View 483 → |
| 17 Jan 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
29 May 2009
21 CFR 600.10(b)
Personnel capabilities
Cited by Michael S Kopf, Melinda L Rice, Richard L Rutherford
29 May 2009
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Michael S Kopf, Melinda L Rice, Richard L Rutherford
29 May 2009
21 CFR 606.160(b)
Required records
Cited by Michael S Kopf, Melinda L Rice, Richard L Rutherford
29 May 2009
21 CFR 640.63(a)
Determining donor suitability
Cited by Michael S Kopf, Melinda L Rice, Richard L Rutherford
Investigators
FDA investigators tied to this site in the record.
Michael S Kopf4 insp.
Richard L Rutherford3 insp.
Eric T Huebler1 insp.
John A Iwen1 insp.
William F Lagud1 insp.
Diane Hall1 insp.
Melinda L Rice1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 600.10(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.63(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.65(b)(8) | 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