Company
United StatesAlexion Pharmaceuticals, Inc., Smithfield, RI – FDA Inspections
Inspection records and compliance data for Alexion Pharmaceuticals, Inc. in Smithfield, Rhode Island. 5 FDA inspections on record, 1 Form 483, last inspected July 21, 2017.
Company Profile
This profile covers Alexion Pharmaceuticals, Inc. based in Smithfield, Rhode Island, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 5
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected February 18, 2011. Last inspected July 21, 2017.
Most cited issue areas
- Procedures for non-sterile drug products1 inspection
- Procedures not in writing, fully followed1 inspection
- Supervisor Training/Education/Experience1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 21, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1019062 |
| August 3, 2016 | VAI | Human Drugs · Drug Quality Assurance | 984855 |
| August 12, 2015 | VAI | Human Drugs · Drug Quality Assurance | 938440 |
| August 22, 2014 | VAI | Human Drugs · Drug Quality Assurance | 892913 |
| February 18, 2011 | VAI | Human Drugs · Drug Quality Assurance | 710477 |
FDA documents
People (5)
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Company Information
Name
Alexion Pharmaceuticals, Inc.
FEI Number
3006568549
Address
100 Technology Rd, Smithfield, Rhode Island 02917, United States
Country
United States
ID: 125aa236-9807-4c76-8057-c66765afea64