Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-03-30.
At a glance
Inspections
7
Form 483s
6
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Mar 2018 – 30 Mar 2018 | Biologics | 483 | On file |
| 2 May 2016 – 13 May 2016 | Biologics | 483 | On file |
| 10 Nov 2014 – 20 Nov 2014 | Biologics | 483 | On file |
| 27 May 2013 – 4 Jun 2013 | Biologics | 483 | On file |
| 28 Sep 2011 | Not recorded | 483 | On file |
| 15 Sep 2009 | Not recorded | 483 | On file |
| 7 Dec 2007 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
Omotunde O Osunsanmi5 insp.
Burnell M Henry2 insp.
Susan M Jackson1 insp.
Mihaly S Ligmond1 insp.
Michael C Kennedy1 insp.
Cynthia Jim1 insp.
Full site report
Get the verbatim findings behind Prothya Biosolutions Netherlands B.V.'s 6 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