Overview
- 11 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-10-27.
At a glance
Inspections
11
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Oct 2023 – 27 Oct 2023 | Human Drugs | Clean | |
| 29 May 2018 – 31 May 2018 | Human Drugs | 483 | On file |
| 19 Mar 2018 – 23 Mar 2018 | Human Drugs | Clean | |
| 12 Sep 2016 – 20 Sep 2016 | Medical Devices & Rad Health | 483 | On file |
| 26 Jan 2015 – 3 Feb 2015 | Human Drugs | Clean | |
| 21 Oct 2013 – 25 Oct 2013 | Human Drugs | Clean | |
| 9 Aug 2012 | Not recorded | Clean | |
| 10 Jun 2009 | Not recorded | 483 | On file |
| 8 Feb 2006 | Not recorded | Clean | |
| 30 Aug 2002 | Not recorded | Clean | |
| 7 Oct 1999 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
MRA M BarbosaR1 insp.
Stephanie C Mangigian1 insp.
Himanshu Gupta1 insp.
MRA GreenC1 insp.
Miguel A Martinez1 insp.
Barbara J Wilimczyk-Macri1 insp.
Viviana Matta1 insp.
James C Maclaughlin1 insp.
Patric C Klotzbuecher1 insp.
Jose A Lopez Rubet1 insp.
Barbara J Rincon1 insp.
Full site report
Get the verbatim findings behind Pliva Hrvatska d.o.o.'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