SOP Templates & Checklists.
Fill in a few details and download an editable template instantly — pre-built starting points for FDA compliance procedures across food, drug, device, and cosmetic operations.
Browse Templates
Pick a template, fill in a few details, and download it. No account required.
FSVP Importer Checklist
Foreign Supplier Verification Program checklist covering hazard analysis, supplier evaluation, and verification activities for food importers.
Food Facility Renewal Checklist
Biennial FDA food facility registration renewal checklist with the data fields, deadlines, and confirmation steps to keep your registration active.
Prior Notice Filing SOP
Standard operating procedure for filing FDA Prior Notice on imported food shipments, including timing rules by transport mode and amendment handling.
Drug Establishment Registration Checklist
Checklist for annual drug establishment registration and listing, covering labeler codes, NDC assignment, and the October–December renewal cycle.
cGMP Self-Assessment (21 CFR 210/211)
Self-assessment questionnaire mapped to 21 CFR Parts 210 and 211 to gauge drug cGMP readiness before an FDA inspection.
U.S. Agent Responsibilities Reference
Reference outlining the role and obligations of a U.S. Agent for foreign establishments across food, drug, device, and cosmetic registrations.
Medical Device Listing Checklist
Checklist for device establishment registration and listing across Class I/II/III, including product code determination and UDI/GUDID readiness.
MoCRA Product Listing Template
Data-capture template for cosmetic product listing under MoCRA, including responsible person details and ingredient statements.
About These Templates
Editable FDA compliance starting points, generated on demand.
What's Included
- FSVP Importer Checklist — Foreign Supplier Verification
- U.S. Agent Responsibilities — Registration requirements
- Food Facility Renewal Checklist — Biennial renewal
- Drug Establishment Checklist — Registration & listing
- Prior Notice SOP — Import filing procedures
- cGMP Self-Assessment — 21 CFR 210/211 reference
How to Use
- 1Pick a template that matches your needs
- 2Fill in a few details (company, dates, names)
- 3Generate and download the document instantly
- 4Customize it for your business and use as a working reference
These are templates, not legal advice. Adapt each document to your specific products and obligations.
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