Updated: Mar 12, 2020
The outbreak of the Coronavirus (COVID-19) has resulted in chaos worldwide, especially after proven to be past containment. The FDA just announced that they will be postponing the majority of foreign inspections through April. Foreign Inspections deemed critical will be dealt with on a case-by-case basis.
So What Led to FDA's Decision?
There are many factors attributing to the FDA's decision, including State Department Level 4 travel advisories, prohibiting U.S. government employees from traveling outside of the United States. Another critical factor, is the confidence FDA has in its ability to maintain oversight over international manufacturers and imported products using alternative tools and methods. The FDA takes different measures when they are not able to physically inspect foreign products. These include denying entry of unsafe products into the U.S, physical examinations at borders, reviewing the firm's previous compliance history and requesting records in advance of on-site inspections.
The FDA will still be working with the 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. This may come from a variety of sources, such as first-time importers unfamiliar with regulatory requirements or repeat offenders trying to skirt the law.
How Will this Affect Incoming Products?
The stop of foreign inspections will place a larger burden on Customs and Border Patrol to ensure that the products coming into the U.S. are not only compliant, but not harmful to consumers. FDA already has safeguards in place to protect our food supply in particular. The Foreign Supplier Verification Program for example is a requirement for any importers of food. Importers must have a plan in place to vet foreign vendors and ensure that those companies are compliant with Current Good Manufacturing Practices.
This shift will limit the abilities of the FDA in visiting foreign companies, but FDA stationed domestically in tandem with Customs will have to modify their strategies for protecting consumers.
For additional information, please visit https://www.fda.gov/