MedImmune has resolved the observations made by the FDA during an annual inspection of its influenza vaccine manufacturing facility in Speke, UK, according to the company. The company had received a Warning Letter from the FDA in May. The UK facility is the bulk manufacturing site for FluMist (Influenza Virus Vaccine Live, Intranasal). MedImmune will continue to work with the FDA on the implementation and ongoing execution of all quality and compliance concerns.

MedImmune is currently working with the FDA on the standard annual lot release process so that FluMist shipments can begin for the upcoming flu season. The company can now proceed in seeking the FDA’s final approval of its sBLA requesting expansion of the vaccine’s indication to include children under five years old.