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Rockville, MD (May 25)-The US Food and Drug Administration issued a Form FDA 483, Inspectional Observations, to the Liverpool, United Kingdom, facility of MedImmune, Inc., citing deviations from current good manufacturing practices.
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:
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.