The consumers in the US enjoy the advantage of foods that are imported from over 150 countries. The Food Safety Modernization Act (FSMA) provides FDA new tools to make sure that the imported foods live up to the US standards and are safe to consumers. According to FSMA, FDA canauthorize third party auditors to certify that foreign food services are adhering to the food safety standards. This article will deal with FSMA.
1. Regulatory Audit
Regulatory Audit is audit of an eligible entity to determine its compliance with provisions of FSMA, resulting in the certification or not of a product (sec 801(q)) or a facility (sec 806(a)).
2. Eligible entity
Eligible entity is a foreign entity, including foreign facility registered under sec 415 that chooses to be audited.
3. Consultative audit
Consultative audit is audit of an eligible entity to determine its compliance with provisions of FSMA, the result of which are of internal purposes.
4. Audit Agent
Audit Agent is an individual qualified to conduct food safety audits on behalf of an accredited third-party auditor.
5. Accreditation Body
Accreditation Body is the authority that performs accreditation of third-party auditors.
6. Third-party auditor
Third-party auditor is a foreign government, agency of a foreign government, foreign cooperative, or any other third-party. A third-party may be a single individual.
7. Accredited third-party auditor
Accredited third-party auditor is a third-party auditor accredited by an accreditation body to conduct audits of eligible entities.
8. Limitations of FSMA
FSMA does not substitute any other FDA inspection.
9. Publicly Available registries
Publicly Available registries are accreditation bodies and accredited third-party auditors.