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.
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.
- 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 email@example.com or 925.807.5100.