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Practice areas

Import Compliance & Regulatory Filings

Product-entry requirements, agency registrations and filings, labeling reviews and responses to FDA, USDA, EPA, DOT, FCC and CPSC inquiries for imported products.

Many imported products must satisfy a U.S. agency in addition to CBP. We help importers and manufacturers identify those requirements before goods ship, prepare registrations and filings, and respond when an agency holds or questions a product.

Scope of representation

  • Entry requirements for FDA, USDA, EPA, DOT/NHTSA, FCC and CPSC-regulated products
  • Import permits, registrations, listings and prior-notice filings
  • Label, marking, document and declaration consistency reviews
  • Agency inquiries, requests for additional information, holds and corrective actions
  • Coordination with customs brokers, testing laboratories and suppliers

Identify the product and the responsible agencies

Customs clearance and product admissibility have to be considered together. We start with the product’s composition, function, intended use, labeling and supply chain. A requirement that applies to one product should not be assumed to apply to every product from the same supplier.

Labels and supporting documents

Labels, specifications, test reports, invoices and entry data should tell the same story. We review them, flag inconsistencies and work with you to close the gaps. Technical testing and certification are coordinated with outside providers; a completed filing is not itself a promise that an agency will admit the goods.

How a matter proceeds

  1. Identify the product and its regulators. Review specifications, intended use and the agencies that may have jurisdiction.
  2. Check the record. Compare labels, certificates, test reports and entry data for gaps or inconsistencies.
  3. File or respond. Prepare the registration, filing or response, and set up a process for future shipments.

Timing and fees

Timing depends on the notice, the agency or court, and the facts. Response dates stated in a notice are reviewed individually as soon as we receive it. Scope, fees and any deposit are discussed before we are engaged and confirmed in a written engagement letter.

Facing a deadline? Call (520) 358-5095. An online appointment request does not extend any government or court deadline.

Documents for an initial review

  • Product photos, labels, specifications, composition and intended use
  • Agency notices, registrations, permits, test reports and prior submissions
  • Entry records, invoices, and manufacturer and importer details
  • A list of pending shipments and any stated response dates

E-mail copies to info@attorneywu.com with the subject “Your name – short description”. Please do not send documents through the chat or the booking form.

Frequently asked questions: import compliance and agency filings

Which U.S. agencies besides CBP may need filings for my imports?

Many products are regulated by “partner government agencies” (PGAs): FDA (food, cosmetics, drugs, medical devices), USDA (plant and animal products), EPA (pesticides, certain chemicals and engines), DOT/NHTSA (vehicles and parts), FCC (radio-frequency devices) and CPSC (children’s and consumer products). Missing registrations, certificates or labeling are a common cause of detentions and refusals. We help with pre-import reviews, registrations, filings and responses to agency holds.

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FDA refused my shipment. What can I do?

An FDA Notice of Action explains why goods are detained or refused and gives a short date to respond. Depending on the reason, options may include submitting evidence that the product complies, relabeling or reconditioning under an approved plan, exporting the goods, or destruction. Missing the response date usually leads to refusal. Send us the notice and the product documents right away.

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General information only, not legal advice. Book a consultation for advice on your situation.

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