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

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

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Record Details

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.

Company: Morgan Gallacher, Inc DBA Custom Chemical Formulators Inc.
Inspection Date: August 23, 2019
Product Type: Drugs
Office: Division of Pharmaceutical Quality Operations IV
Person: Santiago Gallardo Johnson (https://www.fda.gov/media/120628/download)

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ID · edff82e9-0288-43a7-840e-5a05eaadf638