Program Management to Remediate FDA Warning Letter and Import Ban

Problem

After failing an inspection of facilities due to gaps in core quality systems and current Good Manufacturing Practices (cGMP), US Food and Drug Administration (FDA) issued import ban on European manufacturer of dialysis machines. The action against the company's primary products not only affected US sales and its prominent market share, so too were international sales affected as the client was forced to report non-compliance and recalls to competent authorities in markets outside of North American.

Solution

As on-site co-Project Manager at primary manufacturing facility from kick-off to close-out of project, assisted in managing teams consisting of client personnel and consultants at main and auxiliary facilities throughout Europe, US, and Mexico. The focus was to address gaps and remediation of non-compliant issues. A program of change management was undertaken including re-writing and implementing new SOPs, Work Instructions, and processes. Training and monitoring and evaluation to ensure client understood why the problems arose, actions to mitigate future problems, and preparation for a re-audit of facilities were also activities. Risk analysis undertaken to determine if approved products with required changes would require further 510(k) clearance.

Primary software programs used to manage teams and project included Microsoft Project for high-level planning and monitoring. Due to more availability and usage of Microsoft Excel, a tracking spreadsheet was created for each team and site that identified items such as gaps, team leader, task owner, status, deliverables, and due dates. With this, metrics and dashboard reports were created using Microsoft Word, PowerPoint, and Excel. Additionally, Access was later integrated with Complaints Handling Team as that was their primary tool. Regular reports with project and team status metrics were presented to senior management and specific teams (i.e. information directly relevant to the team along with information if that team had linkages to others), as well as full project status deliverables to FDA and legal team per agreed dates for gaps to be remediated. Program also included phase of mock audits using consultants with former FDA experience who were not engaged on the project. Upon close-out, an e-Room was created for the client that held all final deliverables for client as well as hardcopies for library. Following the FDA Quality System Regulation, the following main areas were addressed and modified :

• Design Controls
• Document Controls
• Managements Controls
• Production and Process Controls (P&PC)
• Corrective and Preventive Action (CAPA)
• Labeling and Packaging Control
• Nonconforming Product
• Records - Device Master Records (DMR), Device History Records (DHR), Complaints Handling
• Acceptance Activities

Result

Client passed FDA re-inspection of facilities and import ban was lifted, permitting client to resume sales of compliant product and developing new products adhering to a corporate culture that is more in line with FDA Quality Systems, regaining revenue and improving market share lost during period of non-compliance.

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