Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-03-28.
At a glance
Inspections
7
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Mar 2023 – 28 Mar 2023 | Human Drugs | Clean | |
| 5 Feb 2018 – 13 Feb 2018 | Human Drugs | 483 | On file |
| 10 Nov 2014 – 14 Nov 2014 | Human Drugs | Clean | |
| 9 Jul 2010 | Not recorded | 483 | On file |
| 11 Nov 2005 | Not recorded | Clean | |
| 4 Feb 2004 | Not recorded | Clean | |
| 12 May 2000 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
Matthew B Casale1 insp.
Kathleen R Jones1 insp.
Wayne E Seifert1 insp.
Maria J Lopez- Barragan1 insp.
Meisha R Sampson1 insp.
Meisha R Waters1 insp.
Luis M Burgos Medero1 insp.
Barbara J Breithaupt1 insp.
Full site report
Get the verbatim findings behind Patheon Biologics B.V.'s 2 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