Perhaps your company just completed an ISO 13485 assessment or an FDA inspection and received a list of observations stating that your quality system is not in full compliance. Maybe your company has received a Warning Letter from the FDA. What now?
Regulatory Insight, Inc. can help.
Drawing from many years of experience in responding to ISO 13485 assessment findings, FDA 483s and Warning Letters, Regulatory Insight can devise an effective and comprehensive response to these reports or letters while simultaneously implementing the optimal corrective and preventive actions to place your company back into a good standing with your notified body or the FDA.
Often, the FDA will require a company who receives a Warning Letter to hire a consultant to perform audits and report on the status of the company’s state of compliance to assist the company to return to a compliant state. Even if the FDA has not made this a mandatory condition for clearing your particular Warning Letter, the FDA regards this voluntary action as a serious commitment by your company’s Senior Management to restore your company’s state of compliance. If you received an FDA 483 following an FDA inspection, you may still consider hiring a qualified consultant to assist you with addressing the FDA 483 report items. This proactive approach again alerts the FDA of your strong commitment to compliance and may enable your company to ward off an impending Warning Letter.
Please contact us to learn more about how Regulatory Insight, Inc. can help your company to resolve and correct issues resulting from a quality system inspection or assessment.
