Overview
- 8 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-07-21.
At a glance
Inspections
8
Form 483s
7
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Jul 2017 – 21 Jul 2017 | Human Drugs | 483 | On file |
| 20 Jul 2016 – 3 Aug 2016 | Human Drugs | 483 | On file |
| 4 Aug 2015 – 12 Aug 2015 | Human Drugs | 483 | On file |
| 18 Aug 2014 – 22 Aug 2014 | Human Drugs | 483 | View 483 → |
| 6 Aug 2012 | Not recorded | 483 | On file |
| 18 Feb 2011 | Not recorded | 483 | On file |
| 16 Oct 2009 | Not recorded | 483 | On file |
| 19 Dec 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Nealie C Newberger2 insp.
Megan A Haggerty2 insp.
Jose O Hernandez1 insp.
Edmund F Mrak1 insp.
Michael A Charles1 insp.
William J Leonard1 insp.
Robert C Horan1 insp.
Ramon E Martinez1 insp.
Bo Chi1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Alexion Pharmaceuticals, Inc.'s 7 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, 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