483
Kyowa Kirin Pharmaceutical Research, Inc.Kyowa Kirin Pharmaceutical Research, Inc. – FDA 483, Mar 2, 2020
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.
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ID · 028268d7-a893-4fb4-ac16-704d14aa63c5
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