Owners, operators, or agents in
charge of facilities located within or outside the USA that manufacture,
process, pack, or hold food for consumption in the United States are required
to register the facility with the United States FDA. Facilities that
manufacture, process, pack, or hold food are also required to register unless
food from that facility undergoes further processing (including packaging) by
another non-US facility before the food is exported to the USA.
Examples
of FDA-regulated Foods
- Food and food additives for man or animals
- Dietary supplements and dietary ingredients
- Infant formula
- Beverages
- Fruits and vegetables
- Fish and seafood
- Dairy products and shell eggs
- Raw agricultural commodities for use as food or components of food
- Canned foods
- Live food animals
- Bakery goods, snack food, and candy
What
Information Is Required?
- Name, physical address, telephone number of the facility
- Same information for the parent company, if the facility is a subsidiary
- All trade names the facility uses
- Food product categories
- A statement certifying that the information submitted is true and accurate and submitter is authorized to register the facility
- Name and contact information of the person submitting the certification statement
- Name of foreign facility's U.S. FDA agent and the agent's contact information
- Emergency contact information
acts as a
communications link between FDA and the Malaysia food manufacturer. FDA treats
representations by the Howard Lee Consultancy as those of the Malaysia food
manufacturer, and will consider information or documents provided to the Howard
Lee Consultancy equivalent to providing the information or documents to the
food manufacturer.
We not only
responding to questions concerning your products and assist you and the FDA to
schedule inspections, but ensure that all regulatory responsibilities and
interests of our clients are handled professionally, confidentially and
promptly.
It is our privilege
to help Malaysia food manufacturer do
business in USA. Our experience helps our clients with professional service to
register your company with US FDA, classify and list your products and serve as
US Agent. We provide efficient and personal service to you in complying with
the registration requirements of the US FDA.
在FDA监管的全部进口货物中，食品占65%：从生食海鲜或冷冻海鲜，到成品或预处理食品，不一而足， 包括婴儿配方奶粉、食品配料和添加剂、新鲜水果和蔬菜、干货和罐头食品。我们成功地协助客户将日常食品进口到美国市场。但是，外国食品出口商必须确保其食 品有恰当的标签，产自经FDA注册的工厂，保证食品安全、卫生和优质。
Howard Lee Consultancy 确保食品在出口到美国之前就满足美国政府的所有要求。
食品标签：标签不当的食品最容易被FDA扣留。FDA无须检测食品即可扣留：看一下标签，发现有问题，即予扣留。Howard Lee Consultancy 的客户没有标签问题，出口的食品也不会有问题。请与我们联系，确保贵公司的食品有恰当的标签，确保张贴了要求张贴的所有营养标签。
食品配料：FDA一直在查找未经审批的新食品成分，边境地区最容易找到这些成分。很多食品成分在添加到在美销售的食品中之前，必须满足某些严格的要求。HL Lee Consultancy 审核食品成分，包括新的草药成分、食品色素和味素、以及技术成分，确保符合美国政府对食品配料的要求。
食品工厂注册：为美国市场生产或向美国市场出口食品的每一家外国食品生产商和出口商，必须在食品出口前向FDA 注册。此外，每一家注册的外国工厂必须在注册时委任一家美国代理机构，负责与FDA沟通。Howard Lee Consultancy 是很多家马来西亚食品工厂的美国代理 人，替它们向FDA注册。
对罐装食品的要求：外国罐装食品或酸化食品生产商还适用FDA的其他监管要求。外国灌装厂必须以食品罐装企业 （FCE）的名义向FDA注册，向其提交预定流程，以获得FDA就每个产品签发的SID编号。Howard Lee Consultancy 为出口美国的许多外国食品罐装企业提供低酸性罐装食品和酸化食品服务。