FDA Import Compliance Plan
Product: Coffee | Indo Jack
0. Core Regulatory Framework
- Foreign food facilities MUST register with FDA.
- Each shipment MUST have Prior Notice filed.
- U.S. importer MUST maintain FSVP (Foreign Supplier Verification Program).
- U.S. Agent & FSVP Importer: Different legal roles, but Chicago Accounting fulfills both.
1. Responsibility Split
A. Cofea (Manufacturer) Full Responsibility
PIC: Prihantoro Cahyo
- FDA Food Facility Registration & DUNS Number
- Appointing U.S. Agent (Chicago Accounting)
- Maintaining Food Safety / GMP / HACCP compliance
- Providing all manufacturing & shipment documentation
B. Indo Jack (Brand Side) Operational Control
- Ensure Prior Notice filing per shipment
- Oversee FSVP existence via Chicago Accounting
- Label compliance & Amazon FBA readiness
C. Chicago Accounting Compliance Backbone
U.S. Agent for Cofea + FSVP Importer for Indo Jack. They hold the legal liability for supplier verification.
2. Master Checklist
Manufacturing (Cofea)
| DUNS Number | Exact legal name/address match mandatory. |
| FDA Registration | Register via FURLS; renew every 2 years. |
| Compliance File | HACCP, Shelf-life validation, Lot coding. |
| Amazon Specs | FNSKU printed, Expiry (MM-DD-YYYY), Sealed. |
Import (Indo Jack)
| FSVP Oversight | Confirm Chicago Accounting has the file. |
| Prior Notice | Submit via FDA portal before arrival. |
| Labels | Net weight (oz/g), Origin, Nutrition facts. |
| FBA Prep | ≥270 days shelf life upon arrival. |
3. Portal Directory
| Item | Action |
|---|---|
| DUNS Number | Apply Here |
| FDA Registration | FDA FURLS |
| Prior Notice | Submit Notice |
5. RACI Matrix
| Task | Indo Jack | Cofea | Chicago Acc. |
|---|---|---|---|
| DUNS | — | Responsible | — |
| FDA Reg | Monitor | Responsible | Support |
| U.S. Agent | — | Assign | Responsible |
| FSVP | Oversee | Support | Responsible |
| Labels | Responsible | Provide Data | — |
6. Non-Negotiables
STOP: Do not ship if:
- Cofea is not FDA Registered with a valid DUNS.
- Chicago Accounting has not confirmed the FSVP file is ready.
- Labels do not show both Ounces and Grams.