An FDA inspection doesn’t have to be daunting. Our step-by-step guide provides a roadmap for proactive preparation, covering everything from QMS review to effective FDA-483 responses. By taking a proactive approach, you can ensure your team is ready for a successful inspection outcome.

Foundational Steps: Your QMS and Compliance Manual

Assume a proactive approach with a focus on Quality Management System (QMS) compliance, staff training, and organized documentation. Identify your respective Compliance Program Guidance Manual (CPGM) for your specific industry, and ensure all participants have access to the document well in advance of conducting any mock inspections and identifying and correcting the respective GxP gaps. For more details, review the FDA’s Compliance Program Guidance Manual for inspections.

Reviewing this document with your teams in advance will identify the playbook that FDA Investigators use in the conduct of their inspections and will ensure a well-prepared and confident team going into the inspection process.

Proactive Preparation: Mock Inspections and Gap Analysis

Prepare well in advance by conducting gap assessments, Trial Master File (TMF) audits, training, MOCK Inspections, and preparing corrective actions and preventive actions in response to any observations received. You should also develop story boards that speak to the known issues discovered during the MOCK Inspections, ensuring that all team members are speaking the same narrative surrounding identified issues.

During the FDA Inspection: People and Processes

Identify Key Personnel and Subject Matter Experts

During the actual FDA inspection, ensure that key personnel are identified as well as Subject Matter Experts (SMEs) who will speak to topics raised in the Inspection section of your respective Compliance Program Guidance Manual (CPGM). FDA Investigators want to speak with and question the individuals who performed the operations (e.g., Clinical Trials Operations; Manufacturing Operations) as well as Quality and Executive Management.

Streamline Your Document-Sharing Strategy

Develop a strategy for providing requested FDA Inspection documentation in a timely manner while simultaneously tracking what is provided for your internal records and to aid in any post-inspection response.

After the Inspection: Responding to a Form FDA-483

If a Form FDA-483 is issued at the conclusion of the inspection, be prepared to provide a clear, concise, compelling, complete, and compliant response with supporting documentation of corrective and preventive actions, with actionable dates identified and acted upon within 15 business days. Although a response is not required, a written response must be received within 15 business days if the FDA is to consider it in the event it is considering additional administrative or regulatory action.

Any promises of corrective actions by specific dates should be met. If you are unable to meet them, submit a request for an extension to the FDA that includes a sound rationale and a new date by which the corrective and preventive actions will be completed. Continue to follow the CAPA through to completion while providing the FDA with regular updates on status.

Partner with an Expert

Establish a professional relationship with a company that is highly skilled in the aforementioned remediation process to ensure you can act quickly to address any of the FDA’s concerns. Contact FDAQRC today!