FDA 483 - Professional Compounding Centers of America dba PCCA - April 21, 2023

Professional Compounding Centers of America dba PCCA, an API Repacker/Relabeler in Houston, TX, was cited for three significant observations. These included failures in maintaining appropriate environmental conditions to prevent contamination during repackaging, inadequate transfer of API manufacturer information to customers, and deficiencies in the quality unit's investigation and resolution of critical deviations. The findings indicate serious concerns regarding product quality and safety.