FDA Issues Warning Letter to MedImmune

Rockville, MD (May 24)-The US Food and Drug Administration (www.fda.gov) issued a Form FDA 483, Inspectional Observations, to the Liverpool, United Kingdom, facility of MedImmune, Inc. (Gaithersburg, MD, www.medimmune.com). The plant manufactures bulk monovalent lots used to formulate “FluMist” (influenza virus vaccine live, intranasal). The agency documented deviations to current good manufacturing practice observed during an inspection between Mar. 21 and Mar. 29, 2007.

Specific areas of concern included the following:

• “inadequate investigations” into bioburden excursions relating to five FluMist bulk monovalent lots exceeding virus harvest interim bioburden action limits and the “lack of implementation of appropriate corrective and preventive actions, coupled with deficiencies in aseptic practices by personnel, cleaning validation of equipment, and effectiveness of the cleaning and disinfection processes used.” Adequate and complete investigations of deviations are required by 501(a)2(B) of the Food, Drug, and Cosmetic Act.

• failure to ensure operators who performed setup, sterile filtration, or aseptic processing “use proper aseptic techniques to prevent microbial contamination of monovalent lots”

• a “lack of specificity” in master and batch production records

• failure to establish the effectiveness of cleaning and disinfection processes

• cleaning validation of various equipment; the agency noted it had identified microorganisms associated with eggs during environmental monitoring of the facility and its personnel.

On May 25, MedImmune announced FDA had completed its review of all submissions related to the supplemental biologics license application to extend the age indication of FluMist. According to a prepared statement, the agency also acknowledged the agreed-upon labeling for the vaccine and postmarketing commitments made by the company. Final action on this supplement, however, is postponed until the deviations indicated in the Warning Letter are resolved.