The U.S. Food and Drug Administration (FDA) recently published new draft guidance for FDA staff regarding Sec. 100.250 Food Facility Registration – Human and Animal Food. This FDA guidance, though not final, serves as a reminder to industry of the consequences of not meeting FDA Food Facility Registration Renewal deadline in the Food Safety Modernization Act (FSMA).
FSMA, passed by the U.S. Congress and signed into law by President Obama in 2011, grants the FDA new enforcement powers and imposes new requirements on manufacturers, processors, packers and distributors of foods and beverages. One of the new FDA FSMA requirements is the renewal of food facility registrations, now required every even numbered year starting 2012 (i.e. 2012, 2014, 2016, etc).
Originally, section 415 of the Food, Drug & Cosmetic Act (FD&C Act) simply stated ” owners, operators, or agents in charge of domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are required to register their facilities with FDA, unless an exception applies (see 21 CFR 1.226 and 1.227).” As a result, food facilities had to register only once. Now, after the passage of FSMA, food facilities are required to renew their FDA registration biennially.
Companies have from October 1-December 31 of every even numbered year to renew their food facility registration. Last year, FDA exercised enforcement discretion with food facility registration renewals, granting companies until January 31, 2013. As such, companies that were required to renew their food facility registrations under FSMA and did not do so by January 31, 2013, must re-register.
FDA’s new Guidance for FDA Staff document states that companies that failed to renew their food facility registration within the appropriate timeframe have “committed a prohibited act under section 301 (dd) of the FD&C Act.” Re-register your FDA Food Facility Registration now. FSMA also grants FDA the authority to suspend a company’s food facility registration under certain circumstances.
Registrar Corp is a FDA regulatory compliance firm that assists companies with their Food Facility Registrations, Renewals, and U.S. Agent requirements. As part of its U.S. Agent service, Registrar Corp’s Food Safety Department will perform a Mock FDA Inspection of your facility at no additional charge, other than travel expenses, once FDA has specified a date for the inspection. Registrar Corp also provides Mock FDA Inspections for food facilities that have not designated Registrar Corp as their U.S. Agent or are located in the United States. For such food facilities, Registrar Corp provides the Mock FDA Inspection for a fee.
As part of the Mock FDA Inspection, Registrar Corp will dispatch a food safety expert from the United States to help the company prepare, so that the company knows what to expect when FDA arrives. The Mock FDA Inspection will cover the structure, processes, procedures and documentation used in daily production including (but not limited to) Hazard Analysis (HACCP), Food Defense Plan, GMPs, Food Labeling requirements, etc.
For more information about the Food Safety Modernization Act or any U.S. FDA regulation, please contact Registrar Corp 24/7 at https://www.registrarcorp.com/livehelp or phone Registrar Corp: +1-757-244-0177.