FDABridge
← ব্লগে ফিরে যান
সাধারণ

FDA 이야기 #014 — 폴란드 냉동 피에로기 제조업체에 알레르기 유발 물질 표시가 전혀 없었다

제품은 인도에서 제조되어 두바이로 보내져 재포장된 후 'Product of UAE' 라벨로 미국에 수출되었습니다. 원산지 표시는 그렇게 작동하지 않습니다.

FDABridge দল১ জানু, ২০২৬2 মিনিট পড়ুন

A trading company in Dubai imported bulk spice blends from a manufacturer in Rajasthan, India. In Dubai, they repackaged the spices into retail-sized containers, applied their own brand label, and exported to the United States. The label said 'Product of UAE.'

The product was not a product of the UAE.

문제

Under 19 CFR Part 134, the country of origin is the country where the product was manufactured or where the last substantial transformation occurred. Repackaging — transferring a product from bulk bags into smaller retail containers — is not substantial transformation. The spices were grown, processed, and blended in India. Putting them into smaller bags in Dubai does not change the country of origin. The correct marking was 'Product of India,' regardless of where the repackaging occurred.

US Customs and Border Protection enforces country of origin marking, and the penalties are real: a 10 percent ad valorem marking duty on improperly marked goods, plus the cost of re-marking or re-labeling the entire shipment before it can be released.

문제

The Indian manufacturer had an FDA food facility registration. The Dubai repackaging facility did not — and it needed one, because it was packing food for US consumption. Additionally, the Dubai facility's label used the Indian manufacturer's FDA registration number, which was incorrect because the registration number identifies a specific facility, and the repackaging was happening at a different facility.

We registered the Dubai facility with the FDA, obtained a DUNS number for the Dubai operation, corrected the country of origin to 'Product of India,' and updated the FDA registration number on the label to reflect the repackaging facility. The Indian manufacturer's registration remained active for their facility — both registrations were needed because both facilities were involved in preparing the product for US sale.

교훈

If you buy products from one country, repackage them in another, and export to the US — the country of origin is where the product was made, not where it was repackaged. And both facilities may need FDA registration. This is especially common in Dubai, Singapore, Hong Kong, and other trading hubs. If your supply chain crosses borders, make sure every facility is registered and every label is marked correctly. fdabridge.com/contact.

পরবর্তীতে সাহায্য দরকার?

সেবা নির্বাচনে সাহায্য দরকার?

প্রধান বিকল্পগুলি তুলনা করুন এবং আপনার পণ্যের জন্য সঠিক প্রক্রিয়া বেছে নিন।

আরও পড়ুন

সম্পর্কিত নিবন্ধ

সাধারণ

의료기기 라벨링 기호: 미국 시장 진입을 위해 해외 제조업체가 알아야 할 사항

২৮ এপ্রি, ২০২৬

미국의 의료기기 라벨링에는 적절한 통신을 위해 특정 기호가 필요합니다. 해외 제조업체는 미국 시장에 기기를 수출하기 전에 FDA가 수용하는 기호 기준을 이해해야 합니다.

আরও পড়ুন →
সাধারণ

해외 제조업체를 위한 의료기기 등록: 미국 규제 시스템 가이드

২৬ মার্চ, ২০২৬

해외 의료기기 제조업체는 사업소를 등록하고, 기기를 목록에 등록하며 — 기기 등급에 따라 — 미국에서 유통하기 전에 FDA 허가 또는 승인을 받아야 합니다.

আরও পড়ুন →
সাধারণ

FDA 상담자 를 고용 하기 전 에 질문 할 수 있는 10 가지 질문

২৪ মে, ২০২৬

FDA의 준수 서비스 제공자를 선택하는 것은 중요한 결정입니다. 이 10가지 질문은 외국 제조업체가 능력 있는 컨설턴트를 해결할 수 없는 문제들을 만들어내는 사람들로부터 분리시키는 데 도움이 됩니다.

আরও পড়ুন →