483
UK Health Security AgencyFDA 483 - UK Health Security Agency - May 25, 2021
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.
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ID · ba15b5bc-4ff4-427a-b29a-9c4580e53b78