---
title: "Case Study: International PAI Preparation Audit & Remediation Project | The FDA Group"
description: Learn how The FDA Group planned and executed a successful PAI preparation audit and quality system remediation project for a large healthcare company.
image: https://www.thefdagroup.com/hubfs/fda-CaseStudy-AuditPreparationRemediation-Cover2.jpg
---

| ![](https://www.thefdagroup.com/hubfs/fda-CaseStudy-AuditPreparationRemediation-Cover2.jpg) | Get our free case study # 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). **Read our free case study and learn:** - 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**. [Get the case study »](https://www.thefdagroup.com/case-study-international-pai-audit-remediation#) |
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