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Submit for all FDA-regulated products the correct company name and address of the importer, the manufacturer, delivered-to party, and shipper. Providing the unique number assigned to the company by Dun & Bradstreet (DUNS) or the FDA Establishment Identifier (FEI) provides additional firm-specific information, which assists in finding the companies in FDA’s database.
提交所有受FDA法規監管的產品的進口方的正確公司名稱和地址、生產商、收貨方以及發貨方。提交公司的鄧氏號或者是FDA的FEI號,提交其它公司相關的信息,這有助于在FDA的數據庫中找到公司信息。
Submit “Intended use” information for FDA-regulated products.
受FDA法規監管的產品要提交“既定用途”信息。
U.S. Customs and Border Protection (CBP), which makesinitial decisions before referring shipments to FDA, cites the three mostcommon errors that lead to rejection of entries prior to their beingtransmitted to FDA:
美國海關和邊境保護(CBP),會在貨運物提交給FDA之前做出最初的決策,在此環節導致其傳輸給FDA之前即被拒的3個最常見錯誤是:
Incorrect syntax or omission of required affirmations of compliance;
所需的合規確認句法錯誤或缺失;
Missing or invalid entity information, which identifies companies involved in the manufacture and importation of the product; and,
實體信息缺失或無效,該信息是用于識別產品生產和進口公司的,以及;
Missing or invalid units of measure.
量度單位缺失或無效。 |
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