Seqirus Inc

FDA 483 - Seqirus Inc

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Record Details

Seqirus, Inc., an influenza vaccine manufacturer in Holly Springs, North Carolina, was cited for three observations during an FDA inspection. The firm failed to timely report serious unexpected adverse experiences and follow-up information. Additionally, the inspection revealed inadequate investigations into a power outage affecting classified areas and deficiencies in the quality control unit's procedures for classifying and initiating deviations.

Company: Seqirus Inc
Product Type: Biologics
Office: Atlanta District Office
People: Priscilla M. Pastrana (investigator)
Susan M. Jackson (investigator)
Jamie P. Webb

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ID · fc85c20f-111b-450c-ac9e-643a9be8b060