UK Health Security AgencyMay 25, 2021

FDA 483 - UK Health Security Agency - May 25, 2021

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Record Details

Public Health England was inspected by the FDA, revealing significant deficiencies in its laboratory control systems. The inspection found issues with data integrity, specifically the lack of protection for raw data from alteration or deletion in computerized systems and the absence of audit trail review procedures. Additionally, the firm failed to establish adequate written procedures for investigating invalid host cell protein (HCP) assays.

Company: UK Health Security Agency
Inspection Date: May 25, 2021
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Jose M. Cayuela
Tracy Denison (investigator)

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