FDA and European regulators have been enforcing current Good Manufacturing Practice requirements to an unprecedented degree. GMP inspections are on the rise. Manufacturers and sponsors are responsible for ensuring GMP compliance through the entire supply chain, including, among others, distributors, contract manufacturers, packagers, and raw materials suppliers. Saltbox Consulting can help. Our GMP services include GMP training, GMP compliance reviews, Quality Agreement preparation and enforcement, GMP 483s responses, Warning Letter responses, compliance remediation, administrative appeals, and other FDA enforcement actions.