Uh oh – so you received an FDA-483 or Warning Letter. Don’t despair – you can still resolve your FDA enforcement issues without significant risk to your company. Be clear though: responding to FDA enforcement actions is one of the single most important activities a Quality executive can perform. Development of comprehensive responses to these significant events can dramatically reduce the risk of follow-on enforcement.
However, just responding is not enough.
Comprehensive Responses /
Aggressive Remediation Execution
Comprehensive FDA enforcement responses must be combined with exceptional remediation planning and execution. Program execution requires the ability to integrate FDA quality systems and compliance expertise under an umbrella of rigorous project and program management, to ensure commitments are strictly monitored and deliverables accomplished. Some consulting firms audit. Some simply give advice. Compliance Architects® is uniquely positioned to provide the counsel, strategy, leadership, expertise, hands-on resources and delivery capability to help you respond to enforcement actions and comprehensively conduct the myriad activities necessary to complete remediation plan commitments.