Food

Qualified Facility Attestation

A business that meets the definition of a “qualified facility” is subject to modified requirements of the preventive controls rules. These modified requirements can be met by submitting a form to FDA, attesting to the business’s status as a qualified facility and attesting that the facility is implementing preventive controls to address hazards associated with its food or is in compliance with non-Federal food safety laws and regulations.

The guidance, “Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals,” explains how to determine whether a business meets the definition of “qualified facility” and how to submit the FDA form attesting to its status as a qualified facility. The two forms, Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food) should be used to submit attestations.

Starting October 1, 2018, facilities will be able to submit the qualified facility attestation forms electronically at https://www.access.fda.gov/ via the Qualified Facility Attestation Module. Please note that facilities must have a valid food facility registration to submit their attestation.

For additional Information:

 

Page Last Updated: 09/14/2018
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