Overview
- 18 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-03-22.
At a glance
Inspections
18
Form 483s
4
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Mar 2024 – 22 Mar 2024 | Medical Devices & Rad Health | Clean | |
| 21 Aug 2023 – 29 Aug 2023 | Biologics | Clean | |
| 20 Mar 2023 – 31 Mar 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Jan 2022 – 20 Jan 2022 | Medical Devices & Rad Health | Clean | |
| 23 Jul 2018 – 8 Aug 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Mar 2015 – 16 Mar 2015 | Medical Devices & Rad Health | Clean | |
| 18 Feb 2014 – 19 Mar 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Oct 2012 | Not recorded | WL | View 483 → |
| 21 Apr 2010 | Not recorded | Clean | |
| 1 May 2009 | Not recorded | Clean | |
| 5 Aug 2005 | Not recorded | Clean | |
| 17 Feb 2004 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Mar 2023
21 CFR 820.30(f)
Design verification - output does not meet input requirement
Cited by Mary A Millner, Inga M Warr
31 Mar 2023
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Mary A Millner, Inga M Warr
8 Aug 2018
21 CFR 820.30(g)
Design validation - simulated testing
Cited by Brentley S Collins, Sayeeda Hdabe, Dawn M Braswell, Rhonda Alexander, Latonya T Jiggetts, Tammara A Stephens
Investigators
FDA investigators tied to this site in the record.
Dawn M Braswell4 insp.
Tammara A Stephens3 insp.
Melanie M Walker3 insp.
Leslie W Gilbert2 insp.
Rhonda Alexander2 insp.
Cordelia J Brammer2 insp.
Kimberly C Delk-Brooks2 insp.
Barbara T Carmichael1 insp.
Mary A Millner1 insp.
Inga M Warr1 insp.
Vanessa E Coulter1 insp.
Brentley S Collins1 insp.
Sayeeda Hdabe1 insp.
Latonya T Jiggetts1 insp.
Xiomara Copeland1 insp.
Dellarese L Herbert1 insp.
Claudette D Brooks1 insp.
Trang N Cox1 insp.
Miaja Umaedi1 insp.
Ibad U Khan1 insp.
Kip J Hanks1 insp.
Brandy Davis Brown1 insp.
Myoshi M Francis1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.70(g) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.220(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.260(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.140 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.150 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(a) | 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(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(1) | 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 820.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Artivion, 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