Overview
- 9 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-14.
At a glance
Inspections
9
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 May 2026 – 14 May 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Jun 2023 – 14 Jun 2023 | Medical Devices & Rad Health | Clean | |
| 8 Jan 2018 – 10 Jan 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Mar 2015 – 10 Mar 2015 | Medical Devices & Rad Health | Clean | |
| 20 Dec 2012 | Not recorded | 483 | View 483 → |
| 25 Aug 2010 | Not recorded | Clean | |
| 11 May 2006 | Not recorded | Clean | |
| 25 Aug 2004 | Not recorded | Clean | |
| 20 Nov 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
14 May 2026
ISO 13485:2016 Clause 4.2.5
Procedures for control of records not documented
Cited by Christina D Mello
14 May 2026
ISO 13485:2016 Clause 8.5.2
Corrective action procedures not documented
Cited by Christina D Mello
Investigators
FDA investigators tied to this site in the record.
Christina D Mello2 insp.
Cynthia A Harris2 insp.
Jude C Dike1 insp.
James M Simpson1 insp.
Erin L Mcfiren1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.120 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(b) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.2.5 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.4.1 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hemagen Diagnostics Inc's 3 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