FDA 483 - Morgan Gallacher, Inc DBA Custom Chemical Formulators Inc. - October 26, 2023

This FDA Form 483 report details significant Good Manufacturing Practice deficiencies at Morgan Gallacher, Inc DBA Custom Chemical Formulators Inc. The firm was cited for a range of issues, including a deficient quality control unit, lack of process validation, inadequate equipment cleaning and qualification, and insufficient testing and record-keeping for drug components and finished products. These observations indicate a systemic lack of control over critical manufacturing processes and quality assurance.