Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-04-02.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Mar 2018 – 2 Apr 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Dec 2016 – 9 Dec 2016 | Medical Devices & Rad Health | Clean | |
| 19 May 2014 – 9 Jun 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Jun 2012 | Not recorded | 483 | View 483 → |
| 12 Sep 2011 | Not recorded | WL | View 483 → |
| 17 Nov 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Jun 2014
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Rosanna M Goodrich
9 Jun 2014
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Rosanna M Goodrich
9 Jun 2014
21 CFR 820.40
Procedures not adequately established or maintained
Cited by Rosanna M Goodrich
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 820.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.180(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.200(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | 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 Midmark Corporation'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