Magneco FDA Regulation exports - Food Safety Plans

FDA Food Safety Plans

Generally, domestic and foreign food facilities that are required to register with section 415 of the Food, Drug, & Cosmetic Act must comply with the requirements for risk-based preventive controls mandated by the FDA Food Safety Modernization Act (FSMA) as well as the modernized Current Good Manufacturing Practices (CGMPs) of this rule (unless an exemption applies). It is important to note that applicability of the CGMPs is not dependent upon whether a facility is required to register.

This rule, which became final in September 2015, requires food facilities to have a food safety plan in place that includes an analysis of hazards and risk-based preventive controls to minimize or prevent the identified hazards.


Key Facts of a Food Safety Plan (HARPC) according to FDA rules?

HARPC stands for "Hazard Analysis and Risk-Based Preventive Controls." The term comes from Food Safety Modernization Act (FSMA), through which FDA issued the HARPC regulation (also referred to as the "Preventive Controls Rule" for the food industry on September 17, 2015. Covered facilities are required to have and implement a written food safety plan with the following components:

Hazard Analysis

Known or reasonably foreseeable biological, chemical, and physical hazards (unintentionally but also intentionally introduced)

Preventive Controls

Process, Food Allergens, Sanitation & Other controls

  • Monitoring
  • Correction
  • Corrective Actions
  • Verification

Supply Chain Program

Risk-based supply chain program

Recall Plan

Written recall plan that describes the procedures to perform a recall of the product


Why choose MAGNECO?

If you process certain foods for U.S. consumption without a HARPC plan, your facility may be non-compliant with FDA regulations. MAGNECO offers complete assistance regarding:

  • Existing Food Safety Plans review
  • Complete Food Safety Plan (HARPC) development
  • Full technical assistance from our Food Safety Specialists

Do you have questions?

Contact us now on (+1) 917-622-3409 or via email at