Overview
- 7 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2023-09-08.
At a glance
Inspections
7
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Sep 2023 – 8 Sep 2023 | Human Drugs | Clean | |
| 21 Oct 2019 – 25 Oct 2019 | Human Drugs | Clean | |
| 18 Sep 2017 – 22 Sep 2017 | Human Drugs | Clean | |
| 30 May 2016 – 3 Jun 2016 | Human Drugs | Clean | |
| 17 Feb 2014 – 21 Feb 2014 | Human Drugs | Clean | |
| 27 May 2010 | Not recorded | 483 | On file |
| 11 Jul 2008 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
Saleem A Akhtar1 insp.
MRA McCulloughJ1 insp.
Christopher R Czajka1 insp.
Matthew R Dionne1 insp.
Michael R Goga1 insp.
Kim L Thomas Cruse1 insp.
Nancy G Schmidt1 insp.
Karen E Dorazio1 insp.
Full site report
Get the verbatim findings behind HELSINN BIREX PHARMACEUTICALS LIMITED'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