Kyowa Kirin Pharmaceutical Research, Inc.March 2, 2020

FDA 483 - Kyowa Kirin Pharmaceutical Research, Inc. - March 02, 2020

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Record Details

An FDA inspection of Kyowa Kirin Pharmaceutical Research, Inc.'s biopharmaceutics analytical facility in La Jolla, California, from March 2-6, 2020, revealed a significant data integrity issue. The firm failed to report all precision and accuracy data from method validations associated with multiple studies. This indicates a concern regarding the completeness and reliability of their analytical data.

Company: Kyowa Kirin Pharmaceutical Research, Inc.
Inspection Date: March 2, 2020
Product Type: Biologics
Office: Division of Pharmaceutical Quality Operations IV
People: Sherri N. Rohlf (investigator)
Amanda E. Lewin (issuing_officer)
Melkamu Getie-Kebtie

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ID · 028268d7-a893-4fb4-ac16-704d14aa63c5