Overview
- 14 FDA inspections are on record.
- 11 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-20.
At a glance
Inspections
14
Form 483s
11
EIRs
4
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Nov 2024 – 20 Nov 2024 | Human Drugs | 483 | On file |
| 6 Dec 2023 – 8 Dec 2023 | Human Drugs | 483 | On file |
| 3 Nov 2023 – 10 Nov 2023 | Human Drugs | 483 | On file |
| 22 Feb 2023 – 2 Mar 2023 | Human Drugs | 483 | On file |
| 18 Jan 2023 – 24 Jan 2023 | Human Drugs | 483 | On file |
| 25 Apr 2022 – 2 May 2022 | Human Drugs | 483 | On file |
| 16 Jul 2019 – 2 Aug 2019 | Human Drugs | 483 | On file |
| 1 Oct 2018 – 9 Oct 2018 | Human Drugs | 483 | On file |
| 10 Feb 2014 – 21 Feb 2014 | Human Drugs | 483 | On file |
| 3 Apr 2012 | Not recorded | Clean | |
| 23 Jun 2010 | Not recorded | 483 | On file |
| 18 Apr 2008 | Not recorded | 483 | On file |
Investigators
FDA investigators tied to this site in the record.
Michael Shanks2 insp.
Bo Chi2 insp.
Tara L Breckenridge2 insp.
Geoffrey K Kilili1 insp.
Jacob G Lutz1 insp.
Ogechi C Nna1 insp.
Tyler M Peterson1 insp.
Lauren N Howard1 insp.
Michele L Glendenning1 insp.
Monica E Murie1 insp.
Jill J Tillman1 insp.
Hamet M Toure1 insp.
Robert J Ham1 insp.
Joseph A Piechocki1 insp.
Richard Ledwidge1 insp.
Michele Perry-Williams1 insp.
Tara L Greene1 insp.
Steven D Kehoe1 insp.
Eric M Mueller1 insp.
Michele Perry Williams1 insp.
Warren J Lopicka1 insp.
Full site report
Get the verbatim findings behind Patheon Biologics LLC's 11 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