FDA Temporarily Loosens FSMA On-Site Supplier Audit Requirements for Importers
The Food and Drug Administration is temporarily loosening on-site supplier audit requirements for importers under the agency’s preventive controls and Foreign Supplier Verification Program regulations, it said in a new guidance document. Under both sets of regulations, importers may conduct…
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audits of supplier verification activities, and on-site audits are the preferred verification activity when the supplier controls a hazard that risks serious health consequences or death. But FDA says that travel advisories and restrictions resulting from the COVID-19 pandemic may impact the ability of receiving facilities and FSVP importers to conduct or obtain on-site audits of their suppliers. As a result, FDA will, for the time being, not enforce on-site audit requirements in countries where travel advisories or restrictions due to COVID-19 make it impossible to conduct the on-site audit, as long as an alternative verification activity is selected. The guidance takes effect immediately.