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FDA says it will now only send inspectors out to domestic facilities for “mission-critical” purposes, such as “public health emergencies involving FDA-regulated products.”
The U.S. Food and Drug Administration announced yesterday that it is “scaling back” on routine domestic inspections of facilities that produce FDA-regulated products, including food and dietary supplements, to protect its staff during the current COVID-19 (coronavirus) pandemic. The agency already announced earlier this month that it has suspended inspections of foreign facilities through April.
FDA typically conducts risk-analysis inspections at facilities every few years. FDA says it will now only send inspectors out to domestic facilities for “mission-critical” purposes, such as “public health emergencies involving FDA-regulated products.” Many of FDA’s staff is already teleworking, excluding those engaged in activities such as lab-related activities or monitoring imported products.
The agency is also evaluating how it can conduct regulatory actions in the meantime. It said yesterday: “Importantly, during this interim period we’re evaluating additional ways to conduct our inspectional work that would not jeopardize public safety and protecting both the firms and the FDA staff. This can include, among other things, evaluating records in lieu of conducting an onsite inspection on an interim basis when travel is not permissible, when appropriate.” The agency urged companies to adhere to good manufacturing practices, noting that in the last fiscal year, the violation rate domestically was “only about 5%.”
In a webpage Q&A focusing on food safety in the face of COVID-19, FDA emphasized that “Currently, there is no evidence of food or food packaging being associated with transmission of COVID-19.” As such, the agency said, if a worker at a facility tests positive for COVID-19, “We do not anticipate that food products would need to be recalled or be withdrawn from the market because of COVID-19, as there is currently no evidence to support the transmission of COVID-19 associated with food or food packaging.” The agency also noted that there are no food shortages in the country, despite current low food stock at grocery stores.
Nutritional Outlook thanks the American Herbal Products Association for the tip.