Warning Letter: Quality Management System Remediation

Background

Our client, a large Medical Device company, received a 483 and subsequent Warning Letter from the United States Food and Drug Administration (FDA). The organization received multiple observations for deficiencies related to the following areas of the Quality Management System and ECI was commissioned to conduct a deep dive assessment into the following:

• Post Market Surveillance (21 CFR 803.17, 820.198, subparts for Medical Device Reporting)
• Field Actions (21 CFR 806)
• Design Control and Risk Management (21 CFR 820.30, ISO 14971)
• Nonconforming Product and Corrective and Preventative Action(21 CFR 820.90, 820.100)

Approach and Solution

While the FDA audit identified areas of concern in the company's Quality Management System, the assessment conducted by ECI was intended to identify any other areas of weakness. The activity was intended to provide a holistic review and remediation approach for the Quality Management System.

A team of subject matter experts was engaged to complete the assessment of the Quality Management System documents. The team reviewed approximately 250 documents including Standard Operating Procedures, Divisional Procedures, Work Instructions, and Forms for compliance with FDA and other international regulatory requirements.

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Comprehensive Action

In addition to the areas noted in the Warning Letter, ECI completed the review of the following Quality Management System elements for completeness and regulatory compliance.

• Management Responsibility (21 CFR 820.20)
• Production and Process Controls (21 CFR 820.70, 820.72, 820.75)
• Acceptance Activities (21 CFR 820.80, 820.86)
• Handling, Storage, Distribution, and Installation (21 CFR 820.140, 820.150, 820.160, 820.1700)
• Labeling (21 CFR 820.120)
• Document Control (21 CFR 820.40)
• Purchasing Controls (21 CFR 820.50)

Although the primary scope of the review was FDA regulations, the assessment also considered international requirements, specifically ISO 13485:2016 and EU MDR 2017/745.

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Results

ECI prepared a full assessment, categorized areas as major or minor non-compliances or opportunities for improvement, and provided recommendations for remediation. The client's Quality Management System processes were reviewed for compliance with FDA and other international regulatory requirements through an efficient, cost-effective effort.