With most aspects of the US Food and Drug Administration’s Food Safety Verification Program (FSVP) in place last year, the FDA will begin stricter enforcement of the regulations in 2021. During the Regulatory Agencies Committee (RAC) monthly meeting (a committee of the National Customs Brokers and Forwarders Association of America), FDA’s Assistant Commissioner for Import Operations, Dan Solis, disclosed findings from virtual audits of the FSVP.
Assistant Commissioner Solis stated that while COVID-19 has limited on-site evaluations for compliance with FSVP, the agency has nonetheless proceeded with virtual audits. While overall compliance has been good, he cited the top five insufficiencies below:
|CFR Number||SHORT DESCRIPTION|
|21 CFR 1.502(a)||Develop FSVP|
|21 CFR 1.505(b)||Supplier approval – document|
|21 CFR 1.504(a)||Hazard analysis written|
|21 CFR 1.505(a)(2)||Evaluation – performance, risk|
|21 CFR 1.506(b)||Supplier verification – establish written procedures|
The FSVP is part of the FDA’s Food Safety Modernization Act (FSMA); it was passed into law by Congress in 2011, and its staged implementation began in January of 2016. Importers who fail to comply with the program may be placed on FDA Import Alert, and their products could be refused admission into the US.
For more information regarding the FSVP, consult FDA’s page “FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals” or send questions to Deringer’s Compliance Department.