On May 13, 2016, the U.S. Food and Drug Administration (FDA) released draft guidance for industry on Qualified Facilities under the Food Safety Modernization Act (FSMA) Preventive Controls Rules for Human and Animal Food (“Preventive Controls Rules”). Qualified Facilities enjoy less stringent regulatory obligations under the Preventive Controls Rules. Certain Qualified Facilities however are subject [...]
On April 9, 2015, FDA published a proposed rule in the Federal Register (the “Proposed Rule”) to amend and update its existing regulation on food facility registration. The Proposed Rule would implement provisions of FSMA that require food facility reregistration and changes to the definition of retail food establishments. The Proposed Rule makes additional changes [...]
The Food Safety Modernization Act (FSMA) requires facilities that are required to register under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Sec. 415 of the Federal Food, Drug and Cosmetic Act) to reregister with the U.s> Food and Drug Administration (FDA) on every even-numbered year. This requirement applies to both U.S. [...]
