FDA Issues Draft Guidance for Accreditation Bodies under FSMA

By Susie Hoeller 

The Food Safety Modernization Act (FSMA), requiring the food industry to use third party auditors and certification bodies, under certain circumstances, is designed to greatly improve food safety outcomes for imported foods.  FSMA directs the U.S. Food and Drug Administration (FDA) to establish an accreditation program for these third-party auditors or certification bodies who will then be authorized to: 

  1. conduct food safety audits to assess compliance with the provisions of the Food Drug & Cosmetic Act (FD&C Act) and
  2. issue food and/or facility certifications that the FDA may use to facilitate the entry of foods presented for import

FSMA draft guidanceIn July of 2015, the FDA issued a Draft Guidance regarding Model Accreditation Standards for both third-party auditors (“auditors”) and certification bodies. Here are some of the highlights of the Draft Guidance which are important for companies to consider now before final regulations are issued:  

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