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How to prepare FDA inspection for food manufacturers

Preparing for an FDA preventive control human food inspection involves several key steps to ensure compliance with the Food Safety Modernization Act (FSMA). Here is a general guide to help you prepare:

  1. Understand the Requirements: Familiarize yourself with the specific requirements outlined in the FSMA regulations related to preventive controls for human food. Review the applicable regulations and guidance documents provided by the FDA to gain a comprehensive understanding of what is expected.

  2. Develop a Food Safety Plan: Create a robust food safety plan that includes a hazard analysis, preventive controls, monitoring procedures, corrective actions, verification activities, and a recall plan. Ensure that your plan aligns with the FSMA requirements.

  3. Document Policies and Procedures: Prepare and maintain comprehensive documentation of your food safety policies and procedures. This includes written standard operating procedures (SOPs), records of monitoring activities, corrective actions taken, verification activities, training records, and any other relevant documentation.

  4. Implement Good Manufacturing Practices (GMPs): Establish and adhere to Good Manufacturing Practices, which are the foundational practices that ensure the production of safe and quality food. These practices cover areas such as personnel hygiene, facility sanitation, equipment maintenance, allergen control, and supplier management.

  5. Conduct Internal Audits and Inspections: Regularly conduct internal audits and inspections to assess your facility's compliance with FSMA requirements. This helps identify any gaps or areas that require improvement before the FDA inspection.

  6. Training and Employee Awareness: Ensure that all employees are adequately trained on food safety practices and are aware of their roles and responsibilities in implementing preventive controls. Maintain records of employee training activities.

  7. Mock Inspections and Readiness Assessments: Perform mock inspections and readiness assessments to simulate an FDA inspection. This exercise helps identify potential non-compliance issues and allows you to address them proactively.

  8. Maintain Records: Keep accurate and up-to-date records of your food safety activities, including monitoring and verification records, corrective actions taken, training records, and any other relevant documentation. These records should be readily accessible during the FDA inspection.

  9. Communication and Cooperation: Foster open communication and cooperation with FDA inspectors. Provide them with access to requested records and information promptly and cooperate fully during the inspection process.

  10. Continuous Improvement: Establish a culture of continuous improvement in your food safety program. Regularly review and update your preventive controls based on new information, changes in processes, or emerging food safety risks.

Remember, this is a general guide, and it is important to consult the specific FDA regulations and guidance documents applicable to your facility to ensure compliance with the FSMA requirements.


J&B can help clients to prepare the FDA inspection.


Contact us for help at info@jnbfoodconsulting.com


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