Food Industry | FDA Draft Guidance on Multiple Entity Registration Requirements

/, FDA Enforcement News, Food, Supplier Management/Food Industry | FDA Draft Guidance on Multiple Entity Registration Requirements

Food Industry | FDA Draft Guidance on Multiple Entity Registration Requirements

By | 2018-08-28T14:27:02+00:00 August 28th, 2018|CGMP, FDA Enforcement News, Food, Supplier Management|

Do you own a food company that rents space to conduct any part of your business?

Or, alternatively, do you own a facility that you rent to a food company?

If you answered yes to either of the above questions, keep reading to find out the answer to one question you might have, “Do I need to register with the FDA?”

Guidance

In an effort to help food facilities meet their registration requirements under the Federal Food, Drug and Cosmetic Act (FD&C Act), the U.S. Food and Drug Administration (FDA) issued 2 guidance documents on August 17th 2018.

  1. The 7th edition of the Guidance for Industry: Questions and Answers Regarding Food Facility Registration — a registration requirement guide for owners and operators of facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States.
  2. supplemental draft guidance to the 7th edition — a Q&A on the registration requirements for multiple entities involved in the use of shared physical space.

(NOTE: Want to know what enforcement actions are happening in your supply chain? Get your FREE SUPPLIER ASSESSMENT.)

FDA issued this supplemental Q&A as draft guidance because they continue to receive questions about registration requirements in situations where multiple entities are involved in the use of shared physical space (such as where one entity owns a building and lessees manufacture/process, pack, or hold food in the building).

They drafted this Q&A to clarify who should register in these multiple entity situations. They intend to finalize this guidance by incorporating these Q&As into a future edition of the “Questions and Answers Regarding Food Facility Registration: Guidance for Industry.”

Who Must Register?

In a nutshell, this entire draft document answers 1 question:

In the case of multiple entities, who must register with FDA?

Here, I present the answer in as simple of terms as possible. If you prefer the full FDA answer, please read their document here instead.

Q. Who must register, the lessee or the lessor?

A. The lessee. If you own a food manufacturing or processing company that rents a place to conduct your business, you are required to register. The owner of the building that you are leasing is not required to register.

Q. Who must register, the self-storage facility or the entity storing food in the self-storage facility?

A. The entity storing food. If you rent a self-storage facility to store food, you are required to register. The self-storage facility owner is not required to register unless they are a third-party logistics warehouse and have sole physical control over the food stored in the warehouse.

Q. Who must register, the commercial communal kitchen owner or the companies that use and help maintain that kitchen?

A. The owner and all entities that use the commercial communal kitchen. If you own a communal kitchen and have physical control over the food at any time, such as in a common storage area, you are required to register as well as each company that uses your kitchen to manufacture/process, pack, or hold food.

Q. Who must register, a Third-Party Logistics Warehouse?

A. The owner of the third-party logistics warehouse. A typical third-party logistics warehouse has sole physical control over the food stored and the warehouse is a structure (or establishment) under 1 ownership at 1 general physical location that holds food from many different manufacturers.

Basically, the answer is quite simple — if you have physical control over food as any part of conducting your business (whether or not it’s your company’s food), you are required to register. Note that the supplemental guidance is DRAFT guidance. So if you disagree with the agency’s position or have recommendations – feel free to comment before they finalize the guidance. You can find numerous ways (written or electronic) to submit your comments here (1st paragraph).

To register or not goes the same for all of your suppliers, if you have any. If you need help managing your suppliers (and all of their locations, rented or owned), check out the FDAzilla Enforcement Analytics platform today by getting your Free Supplier Assessment.

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at sales@fdazilla.com.

(RELATED: Shine a light on your supply chain with a FREE FOOD SUPPLIER ASSESSMENT.)

About the Author

Patty Harvey

Patty Harvey, a nationally recognized food expert and speaker, is the Food Product Manager at FDAzilla. Patty joins FDAzilla from PL Harvey Consulting, LLC where she continues to consult for the world’s top food companies.

Leave A Comment