A Governmental Entity Declaration, FDA Form 3422, is included with each invoice for MQSA inspection services.
A facility that believes that it qualifies as a governmental entity needs to complete this Declaration, have it signed by the facility’s Chief Financial Officer or Chief Operating Officer (or equivalent responsible person), and return it to:
MQSA Government Entity Declaration
P.O. Box 6057
Columbia, MD 21045-6057
FDA will review each declaration to determine if a facility qualifies as a governmental entity. Facilities determined by FDA to be governmental entities are exempt from paying FDA-imposed MQSA inspection fees. Facilities in SAC States may still be responsible for paying any SAC-imposed fees.