Medical Device Management & Consulting consulting@regpromedical.com +1 (425) 241 - 3092
RegPro Medical
We know WHAT to do. We do it RIGHT. The FIRST Time.
FDA Inspection / Warning Letter / Audit Response
Major audit non-conformances and FDA 483’s and Warning Letters are significant events that require an immediate, thorough, and professional response. The response and action plans are required within a strict timeline to avoid further regulatory action. Regulatory agencies and Notified Bodies expect an intensive investigation, exhaustive root cause analysis, and detailed action plan with responsibilities, timelines, and effectiveness checks.
What will RegPro Medical Do?
RegPro Medical will provide specialized care and individualized recovery plan to respond to Notified Body audit findings, FDA 483 / warning letter, and other regulatory hurdles. We will support you with fast on-site or remote review of the issue, investigation, and action plan to meet the regulatory timelines. We will assist with your investigation and root cause analysis to help ensure they are complete and accurate. We will help you create an action plan that is detailed, achievable, and effective with realistic timeline and measurable objectives. And we will support you with follow-up to ensure the recovery stays on track until its final close-out.
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FDA 483 / Warning Letter / Audit Major non-conformance
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Support Investigation and Root Cause Analysis
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Help develop effective Action Plan
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Assistance drafting or updating formal response
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Follow-up through close-out by FDA/ Notified Body