# FDA 483 - MedImmune U.K. Limited - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/medimmune-uk-limited/90c6cc7c-2aae-4fd3-a61c-da354f0af2aa

> FDA 483 for MedImmune U.K. Limited on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MedImmune U.K. Limited
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Documents

- [483 - 2022-06-14](https://www.globalkeysolutions.net/records/483/medimmune-uk-limited/da74227b-d0d4-489c-8236-f2dbd359dfe9)
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## Related Officers

- [Omotunde O. Owasanmi](https://www.globalkeysolutions.net/people/omotunde-o-owasanmi/40461380-5907-4228-9a34-aea30a0a24a1)

Company: https://www.globalkeysolutions.net/companies/medimmune-uk-limited/fbddd1ed-5a0c-4c65-a48e-bb2af79482ed

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd