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Surabaya / Tanjung Priok → US port

US import compliance review for FDA and CBP

Product, labels and paperwork checked against FDA and CBP rules before the container leaves Indonesia.

Four areas the review covers

A document-level audit of one product line against the rules a US port applies.

Hand signing a document with a pen
  • FDA facility status

    Registration validity, renewal window, US agent designation. Authority: FDA.

  • Product labeling

    Nutrition Facts, ingredient names, allergens, English text, net quantity. Authority: FDA.

  • Entry documentation

    Invoice, packing list, bill of lading, ISF data, HTS code. Authority: CBP.

  • Product-specific rules

    Lacey Act, LACF and acidified-food filings, plant permits. CBP, FDA, USDA APHIS.

The written report is guidance, not a permit. Only FDA, CBP and their partner agencies issue final rulings.

Where FDA rules trip exporters up

Most refusals we see in coffee, spice, snack and marine-product reviews trace back to these.

01

Lapsed registration

Renew between 1 October and 31 December of each even-numbered year.

02

No US agent

A person or company in the US must take FDA communications.

03

Prior Notice gaps

Filed before arrival for every food shipment; the exporter supplies the data.

04

Missing FSVP file

Food safety plan, hazard analysis, lab tests and supplier records for your importer.

05

Label format

Mandated Nutrition Facts panel, common English names, sesame as the ninth major allergen.

06

Import alerts

Goods on alert can be detained without physical examination.

Before loading, and at the US port

Customs runs on sequence. Some data must leave Indonesia before the container does.

Before loading in Indonesia

ISF 10+2
Transmitted at least 24 hours before the container is loaded
Invoice and packing list
Matched to the HTS line
Origin marking
Every retail unit, normally Made in Indonesia
Lacey Act data
Species, harvest country, quantity and value for wood

At the US port

Prior Notice
Filed with FDA before arrival
CBP Form 3461
Entry at arrival, backed by a customs bond
CBP Form 7501
Entry summary within ten working days
Admissibility
Decided by CBP and FDA

The July 2025 US-Indonesia framework set a 19% baseline tariff on most Indonesian goods. Verify the rate for your HTS line before quoting.

Review fees and timing

Quote-based after a scoping call. Indicative figures dated July 2026, subject to change.

Compliance gap check, one product line 5-7 working days From IDR 6.5 million
FDA registration guidance and US agent coordination 7-10 working days From IDR 8.5 million
Label review, per SKU 3-5 working days From IDR 3.5 million
Full pre-shipment package 15-20 working days From IDR 18 million

Third-party costs (US agent service, broker fees, lab tests, bonds) are billed by those providers and itemised in the quote.

How a review runs

Warehouse floor with a forklift, workers and stacked crates
  1. 01

    Send your product

    Type, packaging photos, and whether you have a US buyer.

  2. 02

    Scoping call

    20-30 minutes to confirm FDA, USDA or Lacey Act scope.

  3. 03

    Written quote

    Within two working days, third-party costs itemised.

  4. 04

    Document intake

    The clock starts when your file is complete.

  5. 05

    Findings and handover

    Fixes ranked by refusal risk, plus licensed partner referrals.

FDA and CBP questions

All 100 answers

Request a US import compliance review

One message with your product and target market. The desk replies with a scoping slot, usually the same working day.

Compliance information, not legal advice. Final rulings rest with FDA, CBP and the relevant US agencies.