5 Imperatives to Address the Remediation Plan for FDA-483 Observations
Author: Mayra I. Rosa-Pagan, Lead Consultant
After facing notification of the regulatory inspection results, it is important to address the findings with diligence and accuracy to complete the commitments satisfactorily. Following are five (5) imperatives to manage your remediation plan.
- Understand the findings
Be certain of understanding the context of all observations and the evidence that was identified during the inspection.
- Timely response
Act immediately to begin the investigation and demonstrate diligence to the Agency. There are specified due dates to respond with adequate action plans to correct and prevent the issues identified during the inspection. Commit to act and deliver results.
- Thorough investigation
Perform a comprehensive investigation, methods and processes must be evidenced showing that root causes were determined and are being addressed.
- Comprehensive response content
Work with your Counsel on the proper documented response. Primary attention must be paid to what is documented, what are the commitments and what evidence is available to demonstrate compliance standing moving forward.
- Management commitment and engagement
Engage all your staff and managers on this remediation process. Ensure personnel are fully aware of the compliance findings and are also trained on the changes implemented to guarantee sustainable improvements and preventive measures.
Contact us for additional information that will help you manage Compliance requirements and applicable initiatives to prevent regulatory compliance issues.
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