Overview
- 6 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2023-01-27.
At a glance
Inspections
6
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Jan 2023 – 27 Jan 2023 | Human Drugs | Clean | |
| 5 Feb 2018 – 9 Feb 2018 | Human Drugs | Clean | |
| 27 Feb 2017 – 3 Mar 2017 | Human Drugs | Clean | |
| 11 Aug 2014 – 15 Aug 2014 | Human Drugs | Clean | |
| 14 Sep 2012 | Not recorded | Clean | |
| 21 Sep 2010 | Not recorded | 483 | On file |
Investigators
FDA investigators tied to this site in the record.
Matthew B Casale1 insp.
Dennis Cantellops Paite1 insp.
Deyaa Shaheen1 insp.
Zachery L Miller1 insp.
Tonya R Johnson1 insp.
Barbara J Wilimczyk-Macri1 insp.
Kristy A Zielny1 insp.
Full site report
Get the verbatim findings behind EirGen Pharma Ltd's 1 Form 483
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