Client Business Situation

Client was a long-established manufacturer of class II durable medical devices designed for mobility assistance.   Due to challenging competitive and other market conditions, client had made a decision within the last five years to move manufacturing from a domestically-based operation to an oversease contract manufacturer.

Client Business Pain

Significant FDA enforcement action was brought on by a major class II recall.   The root cause of the recall was an overseas contract manufacturer's use of off-grade medical device components in the product's manufacture without the appropriate change control, design control, or client notification.  Client had received a Warning Letter within the last two years and was anticipating a follow-up FDA inspection.

Solutions Provided / Services Delivered

Compliance Architects® performed the following services:

• FDA mock inspection to assess FDA inspection readiness;
• Mock inspection gap analysis and recommendations on remediation;
• Significant CAPA review and re-documentation to ensure solid, well-constructed CAPA files for FDA review; and
• Development of an enforcement-committments' matrix to ensure FDA enforcement committments were all thoroughly met.

Benefits Realized

At the end of the engagement the client was in a much better position to receive the anticipated FDA inspection.  Risks related to poorly-documented CAPAs and enforcement response obligations were significantly mitigated.  Gaps identified during the mock inspection highlighting top-tier risk were incorporated into a remediation plan for execution and completion.