Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-31.
At a glance
Inspections
4
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Mar 2026 – 31 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 27 Nov 2017 – 13 Dec 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 Dec 2011 | Not recorded | 483 | View 483 → |
| 22 Apr 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Mar 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Laureen M Geniusz
31 Mar 2026
ISO 13485:2016 Clause 7.4.1
Procedures for purchasing process not documented
Cited by Laureen M Geniusz
31 Mar 2026
ISO 13485:2016 Clause 7.6(a)
Measuring equipment not adequately calibrated or verified
Cited by Laureen M Geniusz
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 820.75(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.86 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.184(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.4.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.6(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind MP Biomedicals Diagnostics Division's 4 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