FDA Mock Audit

Background

Our client, a large medical device company, received several 483 inspectional observations and a subsequent Warning Letter (WL) from the United States Food and Drug Administration (FDA). The cited observations were associated with deficiencies related to Corrective and Preventive Actions (CAPA), Complaints, Medical Device Reporting (MDR) and Design Controls. Because the company indicated through their Warning Letter progress reports that they had resolved the WL violations, a secondary inspection took place which resulted in FDA reissuing major 483 observations (i.e., repeated observations) as well as additional deficiencies.

Approach and Solution

In order to assess company readiness for FDA reinspection, a Quality System Inspection Technique (QSIT)-style mock audit was to determine the company's progress in addressing the nonconformances prior to further reinspection by the FDA. ECI assigned two resources to conduct the audit. The Lead Auditor was a former Recall Branch Director for FDA and a Principal Auditor who also worked with FDA for 8 years.

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Comprehensive Action

An Audit Plan was generated with input from the client to assess responses to the outstanding 483 Observations and Warning Letter violations. The ECI team conducted a 4-day audit of the company's Quality Management System with particular emphasis on the areas where FDA Observations were noted in Medical Device Reporting, Complaints, Recalls, CAPA and Design Controls. All elements of the QMS were not included within the scope of the audit per the client's original request. During the course of the audit, ECI provided the following feedback to the organization.

• Inadequate response from the front and back rooms during Audit Days l and 2 as auditors requested documentation and waited several hours to receive superficial audit responses, lacking attachment references to supporting materials. This observation was discussed with the client on Day 2 of the audit for immediate correction.
• Numerous observations were noted during the audit, some of which indicate that remedies implemented by the client to address the citations observed during FDA inspections and further issued in the WL were inadequate and thereby ineffective.
• Several additional deficiencies were noted within areas of the QMS not previously identified by the FDA including Management Oversight and Controls, Purchasing and Supplier Controls, and Document Controls. It was further noted that the regulatory assessment of device changes was inadequately performed by the company.
• Due to the severity of the observations, significant guidance were provided by ECI Lead Auditor including an overview to distinguish between a device enhancement versus a recall. Other recommendations discussed were implementing a company glossary, remediation of ineffective procedures and practices, and training needs.

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Results

The ECI Mock Audit Report indicated the company lacks a robust quality system that fulfills the required regulatory quality system compliance. The specific violations noted during the mock inspection were not only a repeat of FDA citations but also significant additional subsystem deficiencies. It was further noted the client did not comply with a core Quality System Requirement that specifically relates to Management with Executive Responsibilities to establish the Quality Policy to be understood, implemented, and maintained throughout all levels of the organization, including adequate resources and trained personnel. The fact that all audit findings are aggregated and evident in each of the major subsystems reviewed led to the conclusion that significant remediation was required, and the company was not ready for reinspection.