FDA 483 - Morgan Gallacher, Inc DBA Custom Chemical Formulators Inc. - August 23, 2019

Morgan Gallacher Inc dba Custom Chemical Formulators Inc, a drug manufacturer in Santa Fe Springs, CA, was cited for significant quality control deficiencies during an FDA inspection. The firm released out-of-specification drug products and utilized inadequate reprocessing procedures for expired materials. Additionally, the inspection revealed a failure to conduct annual product reviews and poor controls over computer systems, compromising data integrity.