Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-17.
At a glance
Inspections
5
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 May 2026 – 17 Jun 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Jan 2025 – 18 Feb 2025 | Medical Devices & Rad Health | WL | View 483 → |
| 3 Sep 2014 – 4 Sep 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Feb 2012 | Not recorded | 483 | View 483 → |
| 10 May 2011 | Not recorded | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Jun 2026
ISO 13485:2016 Clause 7.3.3
Design and development inputs not determined
Cited by Eric C Schmitt
17 Jun 2026
ISO 13485:2016 Clause 8.3.1
Nonconforming product not identified and controlled
Cited by Eric C Schmitt
Investigators
FDA investigators tied to this site in the record.
Eric C Schmitt2 insp.
Michael G Mayfield1 insp.
Laurie B Frazier1 insp.
Jeffrey J Thibodeau1 insp.
Janete F Guardia1 insp.
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 820.70(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | 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 820.70(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.3 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.3.1 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind MICROspecialties, LLC's 5 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