FDA Scolds Vaccine Maker And Asks For A Sit Down

In what may be a new get-tough program at the FDA, the agency issued a so-called untitled letter to CSL, a big maker of flu vaccines based in Australia, for flunking an April inspection that found several manufacturing deficiencies. And in addition to demanding a summary of corrective actions that must be taken, FDA officials want to meet with CSL senior execs to review their plan.

The move comes less than a month after CSL recalled its seasonal shot for children in Australia after investigations failed to explain a nine-fold increase in fever and convulsions. However, the FDA also issued a Q&A in which the agency says the manufacting issues are unrelated to the problems that spurred the recall (background here and here).

The FDA cited CSL for “a number of significant objectionable conditions” related a failure to remain in compliance with good manufacturing practices, such as not investigating unexplained discrepancies among batches and not establishing testing procedures designed to assure components conform to appropriate standards of identity strength, quality, and purity. An untitled letter, by the way, is “an initial correspondence” that cites violations that do not meet the threshold of regulatory significance for a warning letter. Interesting – the violations are not serious enough for a warning letter, but serious enough for a sitdown with senior management.