Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-01-28.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Jan 2019 – 28 Jan 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Jan 2018 – 11 Jan 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Apr 2012 | Not recorded | 483 | View 483 → |
| 2 Dec 2011 | Not recorded | 483 | View 483 → |
| 22 Jul 2009 | Not recorded | WL |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Jan 2019
21 CFR 820.30(g)
Design validation - software validation not performed
Cited by Stephen R Souza
28 Jan 2019
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Stephen R Souza
Investigators
FDA investigators tied to this site in the record.
Stephen R Souza4 insp.
Paul M Kawamoto1 insp.
Bryce E Mansfield1 insp.
Sharon I Gundersen1 insp.
Deborah A Nebenzahl1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.180 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Micro Current Technology, Inc.'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