Summary
Cardinal Health Inc. (CAH) announced an amendment to a previously established Consent Decree with the U.S. Food and Drug Administration (FDA) concerning its infusion pumps. This Amended Consent Decree now encompasses all infusion pumps manufactured by or for its subsidiary, Cardinal Health 303, Inc., not just the Alaris SE pumps previously specified. The FDA alleges that certain pumps do not meet the Federal Food, Drug and Cosmetic Act standards, based on a January 2008 inspection.
Key Highlights
- 1Cardinal Health's subsidiary, Cardinal Health 303, has entered into an Amended Consent Decree with the FDA regarding its infusion pumps.
- 2The amendment expands the scope from specific Alaris SE pumps to include all infusion pumps manufactured by or for Cardinal Health 303.
- 3The FDA alleges non-compliance with the Federal Food, Drug and Cosmetic Act based on a January 2008 inspection.
- 4Cardinal Health 303 is required to submit a corrective action plan within 60 days of the decree's entry.
- 5An independent expert will conduct a comprehensive inspection of facilities and certify compliance within 100 days.
- 6Recall procedures will also be inspected by an independent recall expert within 100 days.
- 7The Amended Consent Decree does not affect intravenous administration sets and accessories and permits continued manufacturing, marketing, and sales of infusion pumps (excluding Alaris SE).