Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2021-10-25.
At a glance
Inspections
4
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Oct 2021 – 25 Oct 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Oct 2009 | Not recorded | Clean | |
| 8 Jul 2004 | Not recorded | Clean | |
| 18 May 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Oct 2021
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Miaja Umaedi, Aigbokhai A Dirisu
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Prizm Medical, 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