FDA 483 - Professional Compounding Centers of America dba PCCA - October 29, 2019

An FDA inspection of Professional Compounding Centers of America, Inc. in Houston, TX, identified two significant observations related to quality control and documentation for repackaged drug products. The firm failed to ensure Certificates of Analysis for active pharmaceutical ingredients included complete original manufacturer information and did not test glycerin raw material for harmful contaminants prior to use. These issues indicate deficiencies in the firm's quality assurance processes for repackaging operations.