FSMA REGULATORY AUDIT
FSMA REGULATORY AUDIT
The Food Safety Modernization Act (FSMA), issued by the Food and Drug Administration (FDA) is considered the most comprehensive reformation of the American legislation on food safety matters in 70 years. Contrary to the previous food safety regulations, FSMA is focused on hazards prevention and requires that food business operators guarantee the implementation of safe practices during every step of the supply chain; from the production to the distribution.
The specific FSMA rule Accredited Third-Party Certification is the only voluntary program of the seven.
As a foreign supplier, you are required to comply with the applicable US regulations, but certification is not a mandatory requirement. You can be compliant without being certified. But if expedited entry of the food you supply is a priority for your importer, then chances are your importer will ask you to get FSMA certification.
This is really a valuable exercise for foreign suppliers wanting the full unannounced audit experience, but for internal purposes only, i.e. to assess how close they are to achieving certification.
These certifications are used for two purposes.
- Certifications can establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry of food.
- In rare and specific circumstances FDA can require that an imported product be certified to prevent a potentially harmful food from entering the U.S.
ITA Corporation auditors are qualified regulatory Auditor and industry quality experts who can conduct GMP/Quality Systems audits of suppliers and FSMA certification with our partner accredited certification bodies.
We conduct Consultative Audits for food processors, growers, importers and distributors to let you know what improvements are needed to become fully compliant with FDA state requirements.
Foreign suppliers will greatly benefit from FSMA certification because it reduces the number of requests for proof of FSMA audit and/or other compliance requirements from their US importers. FSMA VQIP certification will also help foreign suppliers to attract more US clients. In addition, foreign suppliers can use their FSMA certification to promote their brands, as they will have a certificate to prove they meet US FDA food safety requirements.
Also, provides extra assurance to US importers and consumers alike, that the food manufactured at the certified facility has passed through a regulatory audit and is manufactured according to US FDA food safety standards.
Contact us to schedule an Audit or submit a form to get immediate assistance.