What did the FDA find wrong with Alexion Pharmaceuticals, Inc.?

The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.

Are Alexion Pharmaceuticals, Inc. products safe to use?

Based on the FDA's findings, consumers should exercise caution. The company was found to have regulatory issues that may affect product safety.

What should I do if I've used Alexion Pharmaceuticals, Inc. products?

If you have used products from Alexion Pharmaceuticals, Inc. and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.

Alexion Pharmaceuticals, Inc. FDA Warning (2017)

Name: Alexion Pharmaceuticals, Inc. FDA Warning (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:22.343721

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on October 19, 2017

MODERATE SEVERITY 2017

Disclaimer: This report is an analysis of a public FDA warning letter. It is not medical advice. If you have consumed these products and feel unwell, contact a healthcare professional immediately.

Executive Summary

The FDA issued a warning letter to Alexion Pharmaceuticals, Inc. on October 19, 2017 citing regulatory violations. The letter was issued by the FDA.

Regulatory Violations

Detailed Analysis

False Claims and Regulatory Violations

The FDA identified regulatory violations in Alexion Pharmaceuticals, Inc.'s operations or product claims.

Potential Health Risks

Division of Pharmaceutical Quality Operations I10 Waterview Blvd, 3rd FLParsippany, NJ 07054Telephone: (973) 331-4900FAX: (973) 331-4969

Ludwig Hanston, CEOAlexion Pharmaceuticals, Inc.100 College StreetNew Haven, CT 06511.

Maya M. DavisCompliance OfficerDivision of Pharmaceutical Quality Operations 1

Regulatory Context

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS# 352798 dated March 22, 2013. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Key Entities Identified

Alexion Pharmaceuticals Inc. FDA Warning Letter

Frequently Asked Questions

What did the FDA find wrong with Alexion Pharmaceuticals, Inc.?: The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
Are Alexion Pharmaceuticals, Inc. products safe to use?: Based on the FDA's findings, consumers should exercise caution. The company was found to have regulatory issues that may affect product safety.
What should I do if I've used Alexion Pharmaceuticals, Inc. products?: If you have used products from Alexion Pharmaceuticals, Inc. and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.

Source Document

This report is based on an official FDA warning letter. The original document is a public record.

View Original FDA Warning Letter

Medical Disclaimer: This report is an analysis of public FDA warning letters. It is not medical advice. If you have consumed these products and feel unwell, contact a healthcare professional immediately. You can report adverse events to the FDA MedWatch program.