Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-12-06.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Dec 2019 – 6 Dec 2019 | Human Drugs | Clean | |
| 11 Nov 2016 – 17 Nov 2016 | Human Drugs | Clean | |
| 23 Sep 2013 – 27 Sep 2013 | Human Drugs | 483 | On file |
| 11 Feb 2011 | Not recorded | 483 | On file |
| 15 Dec 2009 | Not recorded | 483 | On file |
Investigators
FDA investigators tied to this site in the record.
MRA McCulloughJ1 insp.
Tajah L Blackburn1 insp.
Patric C Klotzbuecher1 insp.
Linda L Ng1 insp.
Azza Talaat1 insp.
Brian R Yaun1 insp.
Brooke K Higgins1 insp.
Full site report
Get the verbatim findings behind FRESENIUS KABI IPSUM S.R.L.'s 3 Form 483s
The full inspection record, as Atlas holds it, 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