On May 29, 2007, the Food and Drug Administration (FDA) warned biotechnology company MedImmune Inc. about contamination in its manufacturing plant that could affect its nasal flu spray FluMist, the company’s flu vaccine.

In March 2007, the FDA found bacteria and mold contamination at a very early stage of vaccine production in the company’s Liverpool, U.K manufacturing plant. Federal inspectors said MedImmune did not take steps to control microorganisms in hen eggs used to make the flu vaccine.

The agency also said the company has not taken steps to ensure its workers used proper methods to keep the facility sterile.

MedImmune has been trying to gain FDA approval for FluMist for children as young as one. It is currently approved for ages five to 49.

FDA officials say they factory is not at risk of being shut down because they do not have a product defect at this time. But officials did say the discovery will delay its approval of FluMist for children as young as one until the company develops a plan to correct the problems. In May 2007, an FDA advisory committee approved FluMist for children ages five and younger.

Source: Gregory Lopes, “FDA warns MedImmune of contamination,” Washington Times, May 30, 2007.