Warning Letter: Corrective and Preventative Action

Background

Our client, a large Medical Device company, received several 483 inspectional observations and a subsequent Warning Letter from the United States Food and Drug Administration (FDA). The client received multiple observations for deficiencies related to:

• CAPAs not implementing changes in methods or procedures to correct or prevent the identified quality problems in at least six instances
• CAPAs not adequately verifying or validating the corrective actions to ensure the changes were effective and do not adversely affect the finished device in at least three instances
• Failure to establish CAPA procedures with documentation of activities and results as required by 21 CFR 820.100

Approach and Solution

ECI conducted a holistic review of the company's QMS to identify any other areas of weakness not identified by the FDA inspection observations or warning letter. This assessment supported the remediation approach for the CAPA System. The first phase implementation involved stabilization actions.

‍

Comprehensive Action

A team of subject matter experts reviewed documents including Standard Operating Procedures, Divisional Procedures, Work Instructions, Forms, and open CAPA records. Several tools such as Human Performance, Ishikawa, and 5 Why's were used to identify multiple root causes related to CAPA timing, management empowerment, and human performance.

A CAPA checklist was implemented to achieve stabilization, delineated to include all industry and CFR requirements to be used by CAPA owners and CAPA reviewers. The checklist was tailored to have several sections that matched the CAPA flow phases from the client and was utilized as part of a temporary system control using CAPA inspection until permanent corrective actions were implemented.

Experienced ECI resources adopted the role of "CAPA Mentors" to complete CAPA inspections and collaborate with CAPA owners/approvers. This ensured the timely creation of successful CAPAs that meet regulatory requirements.

‍

Results

The client's CAPA process was brought into compliance through quick stabilization actions that resulted in good quality investigations, finding the root cause and a robust verification of CAPA effectiveness. A remediation project plan was created to ensure that corrective actions were in place for the entire Corrective and Preventive Action System.