Alexion Pharmaceuticals, Inc.
Overview
Alexion Pharmaceuticals, Inc., now a subsidiary of AstraZeneca, is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the development and delivery of innovative treatments. The company is particularly known for its work in research and development in the fields of hematology, nephrology, neurology, and metabolic disorders.
Therapeutic areas
FDA compliance signals
16 FDA enforcement records linked to this company.
- 4832025-03-07
Failure to comply with REMS Implementation System
- 4832024-11-07
Failure to develop written procedures
- 4832024-11-07
Late submission of an ICSR
- 4832024-11-07
Late submission of 15-day report
- 4832024-11-07
Failure to review ADE information
- 4832014-09-26
Late submission of 15-day report
- 4832014-09-26
Late submission of annual safety reports
- 4832014-08-22
Procedures for non-sterile drug products
- 4832014-08-22
Supervisor Training/Education/Experience
- 4832014-08-22
Procedures not in writing, fully followed
- recall — Class I2014-08-13
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
- recall — Class I2014-02-05
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
- warning_letter2013-03-22
FDA Warning Letter (drug product)
- 4832012-08-17
Training--operations, GMPs, written procedures
- 4832012-08-17
Complaint Handling Procedure
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