Overview
- 18 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-27.
At a glance
Inspections
18
Form 483s
6
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Aug 2025 – 27 Aug 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 2 Oct 2024 – 9 Oct 2024 | Medical Devices & Rad Health | Clean | |
| 18 Sep 2023 – 26 Sep 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Nov 2021 – 17 Nov 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 27 Jan 2020 – 31 Jan 2020 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Jul 2017 | Biologics | Clean | |
| 6 Mar 2017 – 10 Mar 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 Jul 2015 – 16 Jul 2015 | Medical Devices & Rad Health | Clean | |
| 24 Jul 2014 | Biologics | Clean | |
| 11 Dec 2012 | Not recorded | Clean | |
| 18 May 2012 | Not recorded | Clean | |
| 18 Aug 2010 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Aug 2025
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Ronald Ifraimov, Mary A Millner
27 Aug 2025
21 CFR 820.181
DMR - not or inadequately maintained
Cited by Ronald Ifraimov, Mary A Millner
27 Aug 2025
21 CFR 820.30(f)
Design verification - output does not meet input requirement
Cited by Ronald Ifraimov, Mary A Millner
27 Aug 2025
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Ronald Ifraimov, Mary A Millner
Investigators
FDA investigators tied to this site in the record.
Barbara T Carmichael5 insp.
Richard K Vogel2 insp.
Lisa A Warner2 insp.
Ronald Ifraimov1 insp.
Mary A Millner1 insp.
Eric C Fox1 insp.
Karen M Rodriguez1 insp.
Karen M Cruz Arenas1 insp.
Adaliz Santaliz-Cruz1 insp.
Laiza V Garcia1 insp.
Valerie J Grecek Trinh1 insp.
Lindsay R Hatch1 insp.
Andrea H Norwood1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 9x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Exactech, Inc.'s 6 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