Form FDA 3942a (for Human Food) is an attestation form for a food facility meeting the definition of a “Qualified facility.” A facility must determine and document its status as a qualified facility on an annual basis no later than July 1 of each calendar year. The attestations required must be:
Submitted to FDA initially:
- By December 17, 2018, for a facility that begins manufacturing, processing, packing, or holding food before September 17, 2018;
- Before beginning operations, for a facility that begins manufacturing, processing, packing, or holding food after September 17, 2018; or
- By July 31 of the applicable calendar year, when the status of a facility changes from “not a qualified facility” to “qualified facility” based on the annual determination; and
- Beginning in 2020, submitted to FDA every 2 years during the period beginning on October 1 and ending on December 31.
When the status of a facility changes from “qualified facility” to “not a qualified facility” based on the annual determination, the facility must notify FDA of that change in status using Form 3942a by July 31 of the applicable calendar year.
