FDA Compliance Setup Form

Complete this form to track your FDA compliance progress for months 2-4

FDA Registration (Form FDA 3510)

FDA registration status

Not started

In progress

Completed

US Agent designation

FDA consultants and PCQIs engaged for product evaluation

Documentation package status

Not started

In development

Under review

Completed

All allergen declarations comply with FDA requirements

Nutrition Facts panels comply with FDA requirements

US importer identification

Not applicable

Identified

In process

Not yet identified

Supplier verification program status

Not established

In development

Partially established

Fully established

Additional compliance notes