Alexion Pharmaceuticals, Inc.
FDA inspection history across 2 sites, 2012 to 2017
- 2
- Form 483s
- 1
- Close-out
- 1
- Warning letter
- 1
- Response
Every document, by year
- Close-out
- Form 483
- Warning letter
- Response
2012: one 483 response and one Form 483; 2013: one warning letter; 2016: one Form 483; 2017: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2012–13One 483 response, one Form 483 and one warning letter, at Cheshire, Connecticut and Smithfield, Rhode Island.
- 2012The longest 483 on file: 5 observations over 4 pages at Smithfield, Rhode Island.
- 2016–17One Form 483 and one close-out letter, at Smithfield, Rhode Island.
Cited most
Across all Alexion Pharmaceuticals observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.160General requirements2
- 21 CFR 211.56Sanitation1
The complete Alexion Pharmaceuticals file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Smithfield, Rhode Island
Two Form 483s · 2012 to 2016 · 8 observations
Latest: Form 483, Aug 3, 2016 →Cheshire, Connecticut
One warning letter and one 483 response · 2012 to 2013
Latest: Warning letter, Mar 22, 2013 →
Also: one document not tied to a site.
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-10-19 | Close-out Close-out letter | — | — | $99 |
| 2016-08-03 | 483 Form 483 | Smithfield, Rhode Island | 3 | $99 |
| 2013-03-22 | Warning letter Warning letter | Cheshire, Connecticut | — | $99 |
| 2012-08-22 | Response 483 response | Cheshire, Connecticut | — | $199 |
| 2012-08-06 | 483 Form 483 | Smithfield, Rhode Island | 5 | $99 |
Investigators on these documents
A. Haggerty (1)Edmund F. Mrak Jr (1)Megan A. Haggerty (1)Nealie C. Newberger (1)
FEI number 3006568549 · most recent document Oct 19, 2017
About Alexion Pharmaceuticals, Inc.
How many FDA Form 483s has Alexion Pharmaceuticals, Inc. received?
FDA Intel has 2 Form 483s on file for Alexion Pharmaceuticals, Inc.; the most recent is dated Aug 3, 2016.
When was Alexion Pharmaceuticals, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Alexion Pharmaceuticals, Inc. is a Form 483 dated Aug 3, 2016, for the site in Smithfield, Rhode Island.
What did FDA cite at Alexion Pharmaceuticals, Inc.?
The regulations cited most in the observations on file for Alexion Pharmaceuticals, Inc. are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.22 (Responsibilities of quality control unit), 3 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times.
Has Alexion Pharmaceuticals, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Alexion Pharmaceuticals, Inc.; the most recent is dated Mar 22, 2013.