Quick answer: Yes — any Indonesian facility exporting food, drugs, devices, or cosmetics to the U.S. must register with the FDA and designate a U.S. Agent. If you export shrimp or spices from Java Island or Lampung Province on Sumatra specifically, a current FDA import alert requires shipment certification due to a Cesium-137 contamination risk. Orionex provides FDA registration and U.S. Agent services for Indonesian exporters starting at $300/year.
A Different Kind of Hazard: Radioactive Contamination, Not Biological
Almost every hazard covered elsewhere in this guide series — Salmonella, heavy metals, pesticide residue — falls into biological or chemical contamination categories. Indonesia's most significant recent FDA action is genuinely different: Cesium-137 (Cs-137), a radioactive isotope, detected in shipments from specific Indonesian regions.
Import Alert 99-52 — What It Actually Requires
Starting October 31, 2025, the FDA began requiring import certification for shrimp and all spices originating from the Island of Java and the Province of Lampung on the Island of Sumatra. FDA's determination was based on Customs and Border Protection detecting elevated Cesium-137 levels in real shipments — including shrimp and cloves — confirmed by FDA's own sample analysis, tied to known contamination sources including radioactive contamination discovered in Serpong, Indonesia.
What this means practically: shrimp or spice shipments from these specific regions require a shipment-specific certificate from an FDA-designated Certifying Entity, submitted through the Import Trade Auxiliary Communications System (ITACS), before the shipment avoids automatic detention. This is not a general Indonesia-wide restriction — it's tied specifically to product type and region of origin.
Who This Actually Affects
This alert does not apply to all Indonesian food exports, or to exporters outside the named regions. If your shrimp or spice products originate from other parts of Indonesia, or if you export other food categories entirely, this specific certification requirement doesn't apply to you — though standard FDA registration, U.S. Agent, and (for spices) the Salmonella kill-step requirements covered in our spice-specific guide still do.
Standard FDA Requirements Still Apply
- FDA Food Facility Registration for food, beverage, and supplement exporters
- Drug Establishment Registration for pharmaceutical manufacturers
- Medical Device Establishment Registration for device manufacturers
- MoCRA Cosmetic Registration for cosmetic manufacturers
- A U.S. Agent for all of the above
U.S. Agent Requirement for Indonesian Facilities
Every Indonesian facility registering with the FDA must designate a U.S. Agent physically located in the United States. Given the specificity and evolving nature of Import Alert 99-52, a responsive U.S. Agent matters — you want to know immediately if FDA guidance affecting your region or product changes.
Orionex Regulatory Solutions is a trusted FDA U.S. Agent for Indonesian exporters, physically based in Casper, Wyoming USA. Learn about our U.S. Agent services →
Indonesian Exporter Compliance Checklist
Register With the FDA in the Correct Category
Food, drug, device, or cosmetic — requirements differ by product type.
Designate a U.S. Agent
Required for all Indonesian exporters.
Check If Your Shrimp or Spices Are From Java or Lampung
If so, arrange certification from an FDA-designated Certifying Entity before shipping.
Renew on Schedule
Food facilities renew biennially — next window: October 1 – December 31, 2026. See our renewal guide.
What Orionex Provides for Indonesian Exporters
The FDA charges no government fee for food facility registration. Orionex's fixed pricing:
- Food Facility Registration + U.S. Agent + Certificate: $300/year
- Drug Establishment Registration + U.S. Agent: $550/year
- Medical Device Establishment Registration + U.S. Agent: $550/year
- MoCRA Cosmetic Registration + U.S. Agent: $650/year
Note: Orionex handles your FDA registration and U.S. Agent designation. If your product is subject to Import Alert 99-52's certification requirement, that certification must come from an FDA-designated Certifying Entity separately — contact us if you'd like guidance.
Why Indonesian Exporters Choose Orionex
FDA Registration & U.S. Agent for Indonesian Exporters — From $300/Year
Orionex handles FDA registration and U.S. Agent services for Indonesian food, drug, device, and cosmetic manufacturers exporting to the United States.