Plasma products manufacturer CSL Ltd (ASX:CSL) has been issued a warning letter from the US Food and Drug Administration (FDA) claiming the company’s manufacture process of an influenza vaccine fails to meet the standard.
The FDA regulates the manufacture, marketing and distribution of CSL’s influenza vaccine, Afluria, in the US market.
According to the letter an inspection into CSL’s influenza facilities in Melbourne identified deviations from good manufacturing practice.
In response, CSL says corrective steps have already been taken and further steps are underway.
In the six months to 31 December 2010, CSL posted a net profit of $500 million.
