Overview
- 18 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-20.
At a glance
Inspections
18
Form 483s
9
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Feb 2025 – 20 Feb 2025 | Biologics | 483 | View 483 → |
| 21 Jul 2021 – 30 Jul 2021 | Biologics | 483 | On file |
| 6 Nov 2017 – 17 Nov 2017 | Medical Devices & Rad Health | 483 | On file |
| 10 Nov 2015 – 20 Nov 2015 | Biologics | 483 | On file |
| 3 Dec 2013 – 10 Dec 2013 | Biologics | 483 | On file |
| 24 Jun 2012 | Not recorded | Clean | |
| 1 Jul 2010 | Not recorded | 483 | On file |
| 16 Jan 2009 | Not recorded | 483 | On file |
| 15 Aug 2008 | Not recorded | 483 | On file |
| 17 Jan 2008 | Not recorded | WL | On file |
| 16 Mar 2006 | Not recorded | Clean | |
| 1 Apr 2005 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
Lack of Written MDR Procedures
Cited by Cody D Rickman, Edward A Brunt, Kimberly M Bigler, Emilia A Sippert
Justification for not reporting
Cited by Cody D Rickman, Edward A Brunt, Kimberly M Bigler, Emilia A Sippert
Lack of or inadequate procedures
Cited by Cody D Rickman, Edward A Brunt, Kimberly M Bigler, Emilia A Sippert
Design Validation - Risk analysis not performed/inadequate
Cited by Cody D Rickman, Edward A Brunt, Kimberly M Bigler, Emilia A Sippert
Contamination control, Lack of or inadequate procedures
Cited by Cody D Rickman, Edward A Brunt, Kimberly M Bigler, Emilia A Sippert
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 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Immucor, Inc.'s 9 Form 483s
Source PDFs 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