New FDA Draft Guidance Explains “Refusal of Inspection”
The U.S. Food and Drug Administration (FDA) conducts inspections of foreign food facilities to ensure that foods produced abroad are safe before they reach the U.S. However, not all foreign food establishments welcome FDA inspectors into their facilities to have a formal look around. Now, the agency’s Food Safety Modernization Act (FSMA) gives FDA the right to deny U.S. entry of imported foods from those establishments who do not grant FDA access to observe their facilities.
This week, FDA released new draft guidance that further explains how and why a “refusal of inspection” might occur. In it, FDA defines refusals as “passive or deceptive tactics employed by foreign entities to delay or avoid inspections or to mislead FDA investigators.” The draft guidance gives plenty of examples to clarify some of the situations that FDA may encounter while checking out a foreign facility.
The draft guidance will be available for public comment for 75 days from its date of publication in the Federal Register. The FDA will consider all comments before completing a final version. Comments should be submitted to Regulations.gov and identified with the docket number listed in the notice of availability that publishes in the Federal Register.