Food Safety Modernization Act (FSMA)

Are You Prepared for the FDA’s Visit?

The Food Safety Modernization Act (FSMA) compliance deadline is SEPTEMBER 2017.

Who must comply?

A facility that manufactures, processes, packs, or holds food and is required to register with the FDA is required to comply with the requirements for hazard analysis and risk-based preventive controls unless it is covered by an exemption.

Our Approach

Manex provides an onsite Food Safety Assessment of your facility with respect to compliance with FSMA rules and critical elements. A detailed plan to address any issues in existing procedures and practices will be presented. Manex delivers results using a team of consultants with expertise in FDA compliance and Food Quality Systems.

The U.S. Food & Drug Administration (FDA) requires
food manufacturers to implement: 

  • A written food safety plan (reanalyze at least once every three years or when changes are implemented).
  • Hazard analysis (biological, chemical, physical hazards, as well as economically motivated adulteration).
  • Preventive controls to mitigate hazards.
  • Monitoring (risk-based environmental monitoring, product testing).
  • Corrective actions.
  • Verification (validation, verification of monitoring, verification of corrective actions, verification of implementation and effectiveness and reanalysis).
  • A supply-chain program.
  • A recall plan.
  • Recordkeeping.
  • Required activities must be overseen by a preventive controls qualified individual (who has successfully completed specialized training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system).

Non-compliance with FDA regulations can result in fines, expensive site visits and temporary and/or permanent closure of facilities.

How Do I Get Started?

For more information or to schedule an appointment, please contact Manex at or 925.807.5100.