FDA 483 - Global Blood Therapeutics, Inc. - August 12, 2019

Global Blood Therapeutics, Inc. in South San Francisco, CA, was cited for two observations during an FDA inspection concerning its investigational new drug processes. The firm failed to properly label investigational new drug packages with the required cautionary statement and lacked adequate records for the quantity of investigational drugs returned from study sites. These issues indicate deficiencies in adherence to regulatory requirements for investigational drug handling and record-keeping.