Overview
- 8 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-10-19.
At a glance
Inspections
8
Form 483s
5
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Oct 2022 – 19 Oct 2022 | Human Drugs | Clean | |
| 8 Jul 2019 – 12 Jul 2019 | Human Drugs | 483 | On file |
| 6 Aug 2018 – 10 Aug 2018 | Human Drugs | 483 | On file |
| 13 Mar 2017 – 17 Mar 2017 | Human Drugs | Clean | |
| 18 May 2015 – 29 May 2015 | Human Drugs | 483 | View 483 → |
| 10 May 2013 – 17 May 2013 | Human Drugs | 483 | View 483 → |
| 10 Oct 2012 | Not recorded | 483 | View 483 → |
| 12 Mar 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
29 May 2015
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Alice S Tsao
29 May 2015
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Alice S Tsao
29 May 2015
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Alice S Tsao
Investigators
FDA investigators tied to this site in the record.
MRA McCulloughJ1 insp.
Margaret M Annes1 insp.
Yvins Dezan1 insp.
Kumar G Janoria1 insp.
Arsen Karapetyan1 insp.
Alice S Tsao1 insp.
Robert C Horan1 insp.
Sandra A Hughes1 insp.
Barbara M Frazier1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Excella GmbH & Co. KG's 5 Form 483s
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