Alicia Mozzachio, branch chief, Division of International Drug Quality, US FDA, CDER/Office of Compliance/Office of Manufacturing and Product Quality.
Deficiencies Found in API Inspections
PIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.
Deficiencies Discovered in API Inspections Suggest Strategies for Improvement