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Compliance

Coordinate FDA food-facility registration when the facility changes owners

Separate the former owner's cancellation from the new owner's registration and preserve the confirmations through the acquisition handoff.

By Institution3 minute readPublished View sources
In this guide

Have the regulatory specialist classify the ownership event

Begin with the legal owner before and after closing, the facility address and the transaction documents. Ask the food-regulatory specialist to confirm that the facility is subject to registration and whether the transaction changes its owner for these rules. A change of operator, agent or contact can require a different action from a change of ownership.

Under 21 CFR 1.234, an ownership change requires the former owner to cancel the facility's registration within sixty calendar days and the new owner to submit a new registration. The provision separately addresses ordinary updates. Do not use an account-profile edit as the closing plan without confirming which legal event occurred.

References: 21 CFR 1.234: food facility registration updates and ownership changes

Build one facility schedule for both sides

Identify every affected facility separately and reconcile the schedule with the transaction's asset and location lists. Record the exact physical location, former registered owner, proposed new owner and existing registration information available to the authorized team. Investigate a facility that appears under an affiliate or predecessor name.

Assign a contact for the seller's cancellation and another for the buyer's registration. Include their authority to act and a dependable confirmation channel. If several facilities transfer on different dates, keep the dates attached to the individual locations rather than applying the first closing date to the entire group.

Arrange the former owner's cancellation evidence

The regulation allows the former owner to authorize an individual to cancel the registration. Confirm who holds that authorization and how the seller will deliver proof that the cancellation was submitted and completed. Keep the required deadline in the transaction checklist with a named owner.

Do not depend on continued access to a departing employee's personal credentials. The parties should use FDA's authorized procedures and retain the relevant confirmation records. If the former owner cannot be reached or disputes responsibility, send the documented facts to the regulatory specialist promptly rather than entering unsupported information on its behalf.

References: 21 CFR 1.234: food facility registration updates and ownership changes

Complete the buyer's new registration process

FDA's registration guidance asks whether a newly owned facility was previously registered and requests the former owner's information. It describes a confirmation process concerning the previous registration. Prepare that information accurately and ensure the people receiving FDA verification messages know their role.

Use the specialist's current requirements for the new registration and establish the correct owner, operator and authorized submitter. Save the submitted information and monitor agency questions. Ask the specialist what must be completed before the buyer begins the relevant activity; the seller's cancellation deadline should not be treated as permission to postpone the buyer's own obligations.

References: 21 CFR 1.234: food facility registration updates and ownership changes; FDA: food facility registration fields

Deliver a completed regulatory handoff

Reconcile FDA's confirmations with the facility schedule and record any item still pending. Give the buyer's compliance owner the new registration evidence, authorized account access and future maintenance responsibilities. Preserve the old registration's cancellation evidence in the transaction archive.

Keep other food permits, inspections and operational authorizations as separate requirements. This registration handoff does not establish that all permissions needed for the facility have transferred. Close the task when both parties' required registration actions are evidenced, with any outstanding agency review assigned to a person who can follow it after the deal team disperses.

Sources

Requirements and product details can change. Check the linked guidance for the facts that apply to your situation.

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