Overview
- 15 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-10-27.
At a glance
Inspections
15
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Oct 2023 – 27 Oct 2023 | Medical Devices & Rad Health | Clean | |
| 22 Aug 2022 – 23 Aug 2022 | Medical Devices & Rad Health | Clean | |
| 1 Nov 2021 – 3 Nov 2021 | Medical Devices & Rad Health | Clean | |
| 3 Oct 2017 – 4 Oct 2017 | Medical Devices & Rad Health | Clean | |
| 19 Sep 2017 – 22 Sep 2017 | Medical Devices & Rad Health | Clean | |
| 4 Apr 2016 – 15 Apr 2016 | Medical Devices & Rad Health | Clean | |
| 18 Nov 2014 – 24 Nov 2014 | Medical Devices & Rad Health | Clean | |
| 27 Jan 2014 – 11 Feb 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Sep 2012 | Not recorded | Clean | |
| 21 Jun 2011 | Not recorded | Clean | |
| 15 Sep 2010 | Not recorded | Clean | |
| 29 Oct 2009 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Feb 2014
21 CFR 820.80(b)
Lack of or inadequate receiving acceptance procedures
Cited by Sonya L Karsik, Jocelyn E Massey, Durell L Giles, Dejon N Harris
11 Feb 2014
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Sonya L Karsik, Jocelyn E Massey, Durell L Giles, Dejon N Harris
11 Feb 2014
21 CFR 820.150
Lack of or inadequate procedures for storage.
Cited by Sonya L Karsik, Jocelyn E Massey, Durell L Giles, Dejon N Harris
Investigators
FDA investigators tied to this site in the record.
Sonya L Karsik4 insp.
Jocelyn E Massey4 insp.
Bryan A Galvez1 insp.
Walden H Lee1 insp.
Juanj Wu1 insp.
Kevin N Tran1 insp.
MDSAP WilliamsA1 insp.
Juanita Banuelos1 insp.
Durell L Giles1 insp.
Dejon N Harris1 insp.
Gene D Arcy1 insp.
Trudy R Papson1 insp.
Carla J Lundi1 insp.
John A Gonzalez1 insp.
Minh D Phan1 insp.
Vashti E Bocker1 insp.
Steven E Porter1 insp.
Jinnie Kokiatkulkij1 insp.
Thao T Kwan1 insp.
Yvette E Guillermo1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.150 | 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 Abbott Vascular Inc's 2 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