The Food and Drug Administration has sent a warning letter to Sanofi's manufacturing plant in Pennsylvania, warning the company to ensure that its flu vaccine batches are not contaminated. The plant produces half of all flu shots in the U.S.
The letter from the FDA is a result of an inspection during last April, which brought up concerns over sterility testing and aseptic conditions. According to the FDA, these concerns have not been addressed. Eleven batches of the vaccine were found to have bacterial contamination earlier on this year.
The letter states that Sanofi Pasteur must respond in writing within 15 working days. If these issues are not addressed, the company could face further action.
No recall is required as the contamination did not reach the finished vaccine. However, the FDA says the company did not investigate the incident effectively. It says Sanofi did not correct ‘objectionable conditions' after two months of discussion.
Approximately 50 million shots of the vaccine are planned by the company for U.S. supplies this year.