Hogan Lovells Update: Re-Registration
From Hogan Lovells:
In new Frequently Asked Questions posted on its website, FDA recently confirmed that it will require all registered facilities to renew their registrations between October 1 and December 31, 2012. This obligation results from Section 102 of FSMA, which requires all registered facilities to renew their registrations in the fall of each even-numbered year. All registered facilities, including those that may have registered or updated their registrations, will need to renew their registration with FDA later this year.
As required by FSMA, facility registrations now need to include an e-mail address for the contact person of the facility (or the U.S. agent for a foreign facility). Additionally, FSMA dictates that registrations must include an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the Federal Food, Drug, and Cosmetic Act. Should FDA determine it necessary, FSMA also permits registration to contain information regarding the categories of foods manufactured, processed, packed, or held at registering facilities.
FDA also is considering adding a voluntary supplement to the registration system whereby a facility profile can be completed and submitted. As discussed in our memorandum of May 15, 2012, FDA has issued an information collection notice requesting comments on its plans to allow voluntary submission of information about the facility type (e.g., manufacturer/processor, repacker/packer, or warehouse/holding facility), the products, hazards, and preventive controls associated with those products, and other facility information (e.g., food safety training, facility size, operational schedule, and number of employees). Comments on these issues are due July 10, 2012.
We recommend that companies begin to review their existing registrations to prepare for the renewal process, identifying all of their registered facilities and registration numbers. FDA explained that as new requirements and guidance go into effect related to facility registration renewal, FDA will post the information on its FSMA website (www.fda.gov/fsma). We expect more detailed instructions from FDA as the time to re-register draws closer.