483
MedImmune U.K. LimitedMedImmune U.K. Limited – FDA 483
Record Details
An FDA inspection of MedImmune UK Limited, a vaccine manufacturer in Speke, Liverpool, revealed significant deficiencies across six observations. Issues included inadequate controls for manufacturing materials, delayed corrective and preventive actions, and poor sterility testing practices. The firm also lacked proper procedures for alarm trending, water system quarantine, and deviation documentation.
- Company
- MedImmune U.K. Limited
- Product type
- biologics
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ID · 90c6cc7c-2aae-4fd3-a61c-da354f0af2aa
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