Recent warning letter from U.S. FDA

摘要

From time to time, we print excerpts from U.S. Food and Drug Administration warning letters that have significance, either because they address an issue that may be a common situation in manufacturing facilities or because they provide an insight into the current concerns of the FDA. The following warning letter has been excerpted to highlight the FDA's guidance. From March 9-24, 2021, the Food and Drug Administration (FDA) conducted a remote Foreign Supplier Verification Program (FSVP) inspection. We also conducted an inspection on November 22, 2019. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1 subpart L. The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards.