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Despite COVID-19, FDA Inspects Importers on FSVP

The U.S. Food and Drug Administration (FDA) has announced a decision to conduct electronic inspections and will request that importers send records required under the FSMA, “Foreign Supplier Verification Program” (FSVP) FDA’s agency. Records requested may be submitted via electronic (or other prompt means) to the Agency due to the travel restrictions, social distancing, and other recommendations associated with the COVID-19.

One requirement under FSVP regulation is to preserve and maintain records of your program, and the FDA has the authority to require that importers provide electronic records. (21 CFR 1.510)

In response to this, Azzule has launched a FSVP compliance module for platform users. This FSVP module integrates seamlessly with Azzule accounts, and is designed to assist in the maintenance and organization of FSVP records. Created with a user-friendly layout and more importantly, our “Download Excel” feature, users can download a FDA-compliant snapshot of their FSVP record-keeping within the click of a button.

This FSVP module is currently available to all Azzule members, FREE OF CHARGE. If you would like to schedule a demo or ask us how our FSVP module works, please contact us at support@azzule.com.

If you need the help of a Qualified Individual (Q.I.) to develop your FSVP program, Azzule also offers Core Support Services. Send us an email at compliance@azzule.com For more information on FDA’s remote review of FSVP records, read their update on the FDA website.