Recently Published FDA Import Refusal Report May Cause Complications for Foreign Manufacturers
Tags: admission, china, CIQ, compliance, contents, declaration, facility, FDA, FDCA, federal, Food drug and Cosmetic act, foreign, GMP, good manufacturing practice, health, import refusal, inspection, labeling, manufacturer, net quantity, origin, Quarantine, regulatory, report, united states, violation
FDA recently made its Import Refusal Report available again on its website. The FDA Refusal Report lists products FDA refused admission into the United States because the product appeared to violate the Federal Food, Drug, and Cosmetic Act (FDCA), and FDA believes that the importer of record failed to present evidence sufficient to demonstrate compliance. Of course, FDA may refuse articles under the FDCA for many reasons unrelated to health or safety: for example, because the product label does not conform to all the technicalities of the FDCA. FDA says it provides the FDA Refusal Report page for the public … READ MORE
