FDA | In-Person FSVP Inspections Shirt to Digital/Remote Format Temporarily
On April 03, 2020; the U.S. Food and Drug Administration announced that it will begin requesting that FSVP importers send records required under the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals rule electronically (or through other prompt means) to the Agency as it shifts to conducting these inspections remotely during the COVID-19 public health emergency. Clients that receive FDA's request to conduct a digital/remote FSVP Records Inspection should contact United Safety Agents at their earliest convenience.
FDA & CDC | COVID-19 Risk Profile for Imported Products and Packages
Currently, there is no evidence to support the transmission of COVID-19 associated with imported goods and there have not been any cases of COVID-19 in the United States associated with imported goods. In general, because of poor survivability of these coronaviruses on surfaces, there is likely very low risk of spread from products or packaging that are shipped over a period of days or weeks at ambient temperatures. Coronaviruses are generally thought to be spread most often by respiratory droplets. Information will be provided on the Coronavirus Disease 2019 (COVID-19) website as it becomes available.
FDA & CDC | Special Cleaning/Sanitation Procedures
CDC recommends routine cleaning of all frequently touched surfaces in the workplace, such as workstations, countertops, and doorknobs. Use the cleaning agents that are usually used in these areas and follow the directions on the label. CDC does not recommend any additional disinfection beyond routine cleaning at this time. View the EPA-registered disinfectant products on the Disinfectants for Use Against SARS-CoV-2 list that have qualified under EPA's emerging viral pathogen program for use against SARS-CoV-2, the coronavirus that causes COVID-19.
Restaurants and retail food establishments are regulated at the state and local level. State, local, and tribal regulators use the Food Code published by the FDA to develop or update their own food safety rules. Generally, FDA-regulated food manufacturers are required to maintain clean facilities, including, as appropriate, clean and sanitized food contact surfaces, and to have food safety plans in place. Food safety plans include a hazards analysis and risk-based preventive controls and include procedures for maintaining clean and sanitized facilities and food contact surfaces. See: FSMA Final Rule for Preventive Controls for Human Food.
FDA | Domestic Food Facility Inspections Scaled Back due to COVID-19
On March 18, 2020; the FDA announced that it will temporarily postpone all domestic routine surveillance food facility inspections. These inspections are traditionally conducted every few years based on a risk analysis. Importantly, all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical.
This announcement comes on the heels of the FDA's March 10th statement that the Agency would be postponing most foreign facility inspections through April and that inspections outside the U.S. deemed mission-critical will be considered on a case-by-case basis as this outbreak continues to unfold.
The FDA will continue to respond to natural disasters, outbreaks and other public health emergencies involving FDA-regulated products.
FDA | Temporary Change in FSVP/FSMA Audit Requirements due to COVID-19
On March 17, 2020, the U.S. Food and Drug Administration issued guidance to communicate their intention to temporarily not enforce supplier verification onsite audit requirements for receiving facilities and importers under the FDA Food Safety Modernization Act in response to the global pandemic of COVID-19. FDA does not intend to enforce the onsite audit requirements if other supplier verification methods are used instead. Specifically, FDA does not intend to enforce the requirement for an onsite audit in the following circumstances:
A receiving facility or FSVP importer has determined that an onsite audit is the appropriate verification activity for an approved supplier, as reflected by its written food safety plan or FSVP; The supplier that is due for an onsite audit is in a region or country covered by a government travel restriction or travel advisory related to COVID-19; Because of the travel restriction or travel advisory, it is temporarily impracticable for the receiving facility or FSVP importer to conduct or obtain the onsite audit of the supplier; and The receiving facility or FSVP importer temporarily selects an alternative verification activity or activities, such as sampling and testing food or reviewing relevant food safety records, and modifies its food safety plan or FSVP to incorporate the alternative activity or activities. The alternative verification activity or activities are designed to provide temporary assurance that the hazard requiring a supply-chain-applied control (or, for FSVP, the hazard that is being controlled by the foreign supplier) has been significantly minimized or prevented during the period of onsite audit delay.
FDA anticipates that receiving facilities and FSVP importers will resume onsite audits within a reasonable period of time after it becomes practicable to do so, and update their food safety plans and FSVPs accordingly. FDA intends to provide timely notice before withdrawing this policy.
FDA | Foreign Food Facility Inspections Suspended due to COVID-19
On March 10, 2020; the U.S. Food and Drug Administration communicated their intention to postpone most foreign food facility inspections through April, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis. The FDA based this decision on a number of factors, including State Department Level 4 travel advisories in which travel is prohibited for U.S. government employees, Centers for Disease Control and Prevention travel recommendations, access restrictions being imposed on foreign visitors by certain countries, guidance from the Office of Personnel Management and the importance of the health and safety of our employees. Another critical factor in taking this action is the confidence we have in our ability to maintain oversight over international manufacturers and imported products using alternative tools and methods.
The FDA stands ready to resume foreign inspections as soon as feasible. As an interim measure, the FDA will employ additional tools to ensure the safety of products imported to the United States. These include denying entry of unsafe products into the U.S., physical examinations and/or product sampling at our borders, reviewing a firm’s previous compliance history, using information sharing from foreign governments as part of mutual recognition and confidentiality agreements and requesting records “in advance of or in lieu of” on-site drug inspections. For example, the FDA has begun exercising this authority when they postponed on-the-ground inspections of manufacturers of FDA-regulated products in China earlier in the outbreak.
The FDA will continue working with U.S. Customs and Border Protection to target products intended for importation into the U.S. that violate applicable legal requirements for FDA-regulated products, which may come from a variety of sources, such as first-time importers unfamiliar with regulatory requirements or repeat offenders trying to skirt the law. The FDA has the ability through our risk-based import screening tool (PREDICT) to focus our examinations and sample collections based on heightened concerns of specific products being entered into U.S. commerce. The PREDICT screening continues to adjust risk scores as necessary throughout the COVID-19 outbreak. As always, the FDA can refuse admission of products that fail sample testing or may violate other applicable legal requirements.
As this remains a dynamic situation, the FDA will continue to assess and calibrate their approach as needed to help advance federal response efforts in the fight against this outbreak.
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