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Don’t be a Target, Learn Best Practices to Mitigate FDA Enforcement

The U.S. Food and Drug Administration (FDA) is in full enforcement mode issuing 260 warning letters in 2021 alone! Now is the time to ensure your products are in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) prior to importation. Manufacturers, importers, distributors, and others engaged in the production or sale of […]

FDA Further Extends UFI Flexibility For Food Facility Registrations

Background on Food Facility Registration The Federal Food, Drug, and Cosmetic Act (“FD&C”) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the U.S. Food and Drug Administration (“FDA”). Additionally, the FDA Food Safety Modernization Act (“FSMA”) amended the food […]

FDA Issues New Guidance to Help Food Facilities Meet Registration Requirements

On May 25, 2018, the U.S. Food and Drug Administration issued a Small Entity Compliance Guide (SECG) to help food facilities meet their registration requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act requires food facilities engaged in manufacturing/processing, packing, or holding of food for human or animal consumption in […]

FDA Takes New Steps in Oversight of Imported Foods

FDA announced that it has recognized the first accreditation body under the voluntary Accredited Third-Party Certification Program created by the FDA Food Safety Modernization Act (FSMA). The organization being recognized is ANSI-ASQ National Accreditation Board (ANAB), an organization jointly owned by the American National Standards Institute (ANSI) and the American Society for Quality (ASQ) based […]

FDA Announces Enforcement Discretion Under FSMA

On January 4, 2011, Congress enacted the Food Safety Modernization Act (FSMA), aiming to protect the public by ensuring the U.S. food supply is safe through prevention and enforcement. The FSMA included seven foundational rules, which we summarized in our FSMA: Stay Compliant with DTL’s ‘PICTURE’! blog.

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