jueves, 10 de noviembre de 2016

FDA Law Blog: FDA Updates Its Food Facility Registration Guidance

FDA Law Blog: FDA Updates Its Food Facility Registration Guidance
Posted: 09 Nov 2016 09:56 PM PST
By Ricardo Carvajal –
FDA recently announced the issuance of the 7th edition of the Agency's Questions and Answers Regarding Food Facility Registration.  The latest edition includes nearly 60 new Q&As on a variety of registration-related topics, including:
  • Biennial registration renewal – A facility’s registration must be renewed in the last quarter of every even-numbered year.  The new Q&As address scenarios such as a facility’s obligation to renew even when an initial registration has been submitted during any of the first three quarters of a biennial renewal year.
  • Unique Facility Identifiers (UFIs) – Although these won’t be required as part of a registration until October 1, 2020, a number of new Q&As address verification and selection of UFIs.  Currently, a DUNS number is FDA’s preferred UFI, but FDA might deem other UFIs acceptable before the requirement takes effect.
  • Food product categories and activity types – A registration must include information on food product categories and the types of activity handled by the facility.  The guidance now makes clear that a facility such as a warehouse that frequently changes food product categories “may select all of the food product categories that are normally part of [its] operations.”  The guidance also provides definitions of the different activity types (e.g., “refrigerated human food warehouse/holding facility”).
  • Cancelation of registration – Among other things, the guidance explains the circumstances under which FDA will cancel a registration, and the agency’s process for informing the registrant.
  • Waiver requests – As of January 4, 2020, registration-related submissions will have to be in electronic format unless FDA grants a waiver.  New Q&As explain the process for obtaining a waiver.
Comments on the guidance are due by February 6, 2017.