Medical Device Warning Letter Remediation Assistance

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 overseas 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-commitments’ matrix to ensure FDA enforcement commitments 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.

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