Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-23.
At a glance
Inspections
7
Form 483s
2
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 May 2025 – 23 May 2025 | Biologics | Clean | |
| 9 Jan 2023 – 17 Jan 2023 | Biologics | Clean | |
| 30 Aug 2018 – 7 Sep 2018 | Biologics | 483 | On file |
| 10 Jun 2013 – 13 Jun 2013 | Medical Devices & Rad Health | Clean | |
| 9 Feb 2012 | Not recorded | Clean | |
| 23 Sep 2010 | Not recorded | 483 | View 483 → |
| 6 May 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Sep 2010
21 CFR 820.50(a)
Evaluation of suppliers, contractors, etc., requirements
Cited by Terry C Kimball
Investigators
FDA investigators tied to this site in the record.
Celeta S Coves1 insp.
Kaarin M Slotte1 insp.
Gene D Arcy1 insp.
Creighton T Tuzon1 insp.
Nicole M Li1 insp.
Krishnakum Devadas1 insp.
Richard A Lewis1 insp.
Laurie B Frazier1 insp.
Michael J Nerz1 insp.
Terry C Kimball1 insp.
Maribeth G Grattan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Abbott GmbH'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