Overview
- 9 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2015-02-11.
At a glance
Inspections
9
Form 483s
4
EIRs
5
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Feb 2015 – 11 Feb 2015 | Human Drugs | 483 | On file |
| 18 Mar 2013 – 29 Mar 2013 | Human Drugs | 483 | On file |
| 6 Jan 2012 | Not recorded | 483 | On file |
| 3 Sep 2010 | Not recorded | 483 | On file |
| 31 Jan 2008 | Not recorded | Clean | |
| 3 May 2007 | Not recorded | Clean | |
| 16 Jul 2004 | Not recorded | Clean | |
| 6 Dec 2001 | Not recorded | Clean | |
| 5 Nov 1999 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
Erika V Butler2 insp.
Kimberley A Hoefen2 insp.
Michael A Charles1 insp.
Zachery L Miller1 insp.
Paul Z Balcer1 insp.
Zachary L Stamm1 insp.
Steven C Madzo1 insp.
Ginger M Sykes1 insp.
Susan F Laska1 insp.
Full site report
Get the verbatim findings behind Amgen, Incorporated's 4 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