A European manufacturer began to experience significant FDA compliance issues following an expansion of exports to the U.S. When the quality system proved ineffective in correcting the problems, the Company contracted with Anson for assistance. Anson Group audits revealed some correctable training, procedural and training problems, and also some cultural issues that would take some time to overcome.

Anson Group developed a long-term support arrangement that focused on the most critical needs and were adjusted as the Company’s FDA compliance status improved:

• Direct advisory support to senior management for risk assessment, corrective actions and resource allocation

• Periodic QAS auditing and follow-up training programs advisory support to key middle management personnel

• Immediate assistance in dealing with inspections and serious FDA compliance issues

• Assuming FDA correspondent and liaison services, including new product approval submissions and mandatory reporting