The FDA has sent a warning letter to Sanofi’s manufacturing plant in Pennsylvania, USA. The letter tells the company to make sure future batches of flu vaccine are not contaminated. The plant produces half of all flu shots in the USA.
This is after the FDA had brought up concerns regarding problems with sterility testing and aseptic conditions during an inspection last April. This warning letter has come because the company has not addressed the concerns, according to the FDA.
The warning letter states that Sanofi Pasteur must respond in writing within 15 working days. If things are not sorted out the company could face further action.
Eleven batches of monovalent concentrate were found to have bacterial contamination earlier on this year. Monovalent concentrate is an intermediate derived from one of the three influenza virus strains. It is used to produce Fluzone (a flu vaccine).
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 talks.
A spokesman for Sanofi Pastaur said the company does not expect this incident to affect production. The FDA added that this incident is not expected to significantly affect the flu shot stocks for the coming flu season.
50 million shots of Fluzone are planned by the company for US supplies this year – about 50% of the country’s needs. Sanofi Pasteur is producing fewer this year than last because other manufacturers are also producing it.
This plant in Pennsylvania is the same one that is expected to produce avian influenza (bird flu) shots in the event of a human outbreak.
Written by: Christian Nordqvist
Editor: Medical News Today