Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-03-22.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Mar 2024 – 22 Mar 2024 | Biologics | 483 | View 483 → |
| 29 Apr 2019 – 2 May 2019 | Biologics | 483 | View 483 → |
| 18 Jul 2016 – 20 Jul 2016 | Biologics | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Mar 2024
21 CFR 606.60(a)
Provide proper equipment to meet requirements
Cited by Ramon L Gonzalez-Prieto
Investigators
FDA investigators tied to this site in the record.
Ramon L Gonzalez-Prieto1 insp.
Everard A Irish1 insp.
Judy E Ciaraldi1 insp.
Yaw O Osei1 insp.
Angel F Colon1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.60(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.10(e)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Octapharma Plasma, Inc.'s 2 Form 483s
Source PDFs, 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