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International PAI Audit Preparation & Remediation Project

Between June and December of 2018, The FDA Group partnered with a large healthcare product company to support a Pre-Approval Inspection (PAI) audit preparation project and subsequent quality system remediation efforts at a site within the European Union (EU).

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  • What prompted a major international healthcare company to seek support for significant compliance projects
  • How The FDA Group worked closely with the company's quality and compliance personnel to prepare an assessment, implement training, conduct comprehensive remediation, and more.
  • How The FDA Group completed this project on time and 15% under budget.
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