Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-10-19.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Oct 2022 – 19 Oct 2022 | Human Drugs | Clean | |
| 4 Sep 2019 – 5 Sep 2019 | Human Drugs | Clean | |
| 3 Apr 2018 – 11 Apr 2018 | Human Drugs | 483 | On file |
| 18 Sep 2014 – 26 Sep 2014 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Sep 2014
21 CFR 211.42(a)
Buildings of Suitable Size, Construction, Location
Cited by Santos E Camara, Barbara J Breithaupt
26 Sep 2014
21 CFR 211.42(b)
Product flow through building is inadequate
Cited by Santos E Camara, Barbara J Breithaupt
26 Sep 2014
21 CFR 211.46(b)
Equipment for Environmental Control
Cited by Santos E Camara, Barbara J Breithaupt
26 Sep 2014
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Santos E Camara, Barbara J Breithaupt
Investigators
FDA investigators tied to this site in the record.
MRA McCulloughJ1 insp.
Zachary A Bogorad1 insp.
Steven P Donald1 insp.
Santos E Camara1 insp.
Barbara J Breithaupt1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Fresenius Kabi Deutschland GmbH's 2 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