Free Newsletter
Baxter tests point to Chinese problem
Baxter is zeroing in on the possibility that a supplier's uninspected Chinese plant faltered while processing the active ingredient in its heparin drug, the Los Angeles Times reports. Testing found irregularities in samples processed in China; the same irregularities were absent from samples from the same supplier's Wisconsin plant. When the Times sent a reporter to the Chinese plant, guards turned him away, but an unrelated heparin-making facility nearby let him in to see its thumbprint-access security system and other safeguards.
You'll recall that Baxter stopped making its multiuse vials of heparin after the FDA received reports of hundreds of adverse reactions to the med. The company also recalled some 32 million vials. Much of the active ingredient in the drug came from a plant in China never inspected by Chinese or U.S. regulators.
Related Articles:
FDA inspected wrong Chinese plant. Report
Congressman: FDA chief should resign. Report
Chinese plant linked to recalled heparin. Report
Baxter stops making multidose heparin. Report
Baxter recalls heparin on adverse events. Report
Comments
Post new comment
Paid Research Reports
- The Specialty Pharma Market Outlook: Key players, new company growth models and emerging opportunities
- Investigating Clinical Trial Costs: Comparative analysis of trial cost components in key geographies
- Clinical Trial Recruitment Strategies: Optimizing patient recruitment and retention in late stage clinical trials
- Pipeline Insight: Therapeutic Cancer Vaccines - Prospect of first approval set to reinvigorate interest from major companies
- Stakeholder Opinions: Vaccines in Emerging Markets (Asia) - Opportunities in China, India, South Korea and Taiwan
- Big Pharma Performance Before, During and Beyond the Global Recession





