483
Sunil S. Dhawan, MDFDA 483 - Sunil S. Dhawan, MD - October 07, 2015
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An FDA inspection of Center for Derm. Clinical Research, Inc. in Fremont, CA, revealed a significant issue with maintaining accurate case histories. The firm failed to consistently document patient complaints and adverse events from patient diaries into Case Report Forms, impacting the integrity of clinical investigation data.
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