FDA warns Novartis over contaminated vaccines
The FDA has warned Novartis Vaccines and Diagnostics of the "significant deviations" found at its manufacturing plant in Marburg, Germany, accusing the pharma giant of producing contaminated vaccines and failing to come up with a comprehensive response to the problem. In a letter to Novartis Vaccines CEO Joerg Reinhardt, the FDA said an inspection last September "documented a number of significant deviations from current good manufacturing practices in the manufacture of your Rabies Vaccine and Diphtheria and Tetanus Toxoids Adsorbed concentrate." The agency went on to chide the company for failing to come up with a comprehensive plan to correct the issues and warned of new regulatory actions that could follow.
- check out the FDA letter