US FDA Certification Services

Service Details:

US FDA Registration Services Food and Drug Administration (FDA or US FDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, bio pharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED) and veterinary products.

Which products does FDA regulate:

Foods:

• Safety of all food products (except for most meat and poultry products, which are regulated by the U.S. Department of Agriculture)

• Labelling

• Bottled water

• Food additives

• Infant formulas

Dietary Supplements:

Human Drugs:

• Product approvals

• OTC and prescription drug labeling

• Drug manufacturing standards

Vaccines, Blood Products, and Other Biologic:

• Product and manufacturing establishment licensing

• Safety of the nation's blood supply

• Research to establish product standards and develop improved testing methods

Medical Devices:

• From simple items like tongue depressors, to complex technologies such as heart pacemakers

• Premarket approval of new devices

• Manufacturing and performance standards

• Tracking reports of device malfunctioning and serious adverse reactions

Electronic Products:

• Products that give off radiation, such as microwave ovens and X-ray equipment

• Radiation safety performance standards for microwave ovens, television receivers, diagnostic

• X-ray equipment, cabinet x-ray systems (such as baggage x-rays at airports), laser products

• Ultrasonic therapy equipment, mercury vapour lamps, and sunlamps

• Accrediting and inspecting mammography facilities

Cosmetics:

• Safety

• Labelling

Veterinary Products:

• Livestock feeds

• Pet foods

• Veterinary drugs and devices

• Veterinary biologic not regulated by USDA are considered new animal drugs

Service Details:

CDG provides you compliance services for US FDA Foreign Supplier Verification Program. The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. The FDA FSMA rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals is final, and the first compliance dates begin May 30, 2017. It is a program that importers covered by the rule must have in place to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the suppliers food is not adulterated and is not misbranded with respect to allergen labeling. certain categories of imported food are not covered by FSVP. These include: Juice, fish, and fishery products subject to and in compliance with FDAs Hazard Analysis and Critical Control Point (HACCP) regulations for those products, and certain ingredients for use in juice and fish and fishery products subject to the HACCP regulations. Food for research or evaluation Food for personal consumption beverages and certain ingredients for use in alcoholic beverages Food that is imported for processing and future export Low-acid canned foods (LACF), such as canned vegetables, but only with respect to microbiological hazards covered by other regulations, as well as certain ingredients for use in LACF products (but only with respect to microbiological hazards). Certain meat, poultry and egg products regulated by the U.S. Department of Agriculture at the time of importation. CDG will get you ready for FSVP inspection & audits

Service Details:

The FDA Food Safety Modernization Act (FSMA) is transforming the nation’s food safety system into one that is based on the prevention of foodborne illnesses. It will be a system in which the food industry systematically puts in place measures proven effective in preventing contamination.

Keeping food safe to eat is paramount, no matter where it is produced, whether conventional or organic, whether the operation is small, medium or large, whether it’s produce or processed foods.

The FDA has finalized the foundational rules that will implement FSMA, including the Preventive Controls rules for Human and Animal Food, the Produce Safety rule, and the Foreign Supplier Verification Programs (FSVP) rule. There will be extensive outreach to industry to help ensure that everyone who seeks to comply with these rules, whether legally required to or not, understands the new requirements. The compliance dates vary, in part, according to the size of the business.

Food industry training will be an important component of successful implementation. The Produce Safety Rule and the Preventive Controls rules all have training components, although they are not the same for each rule. There will be ample time for farmers and food producers to come into compliance. Compliance dates for the rules are staggered according to the size of the business.

Be prepared for FSMA inspections. Tailored to meet your needs, our FSMA audits are adapted to each site, focus on specific requirements not already covered in your food safety systems, and can include bespoke requirements as well as hazard-specific controls:

• FSMA pre-certification audits to prepare for accredited FSMA certification
• Gap assessments and gap audits
• Food defense (intentional adulteration) audits
  • Compliance audits for intentional adulteration (IA) rule
  • Vulnerability assessment of facilities
• Preventive controls audits
• FSMA addendum audits for GFSI standards
• FSMA Importer Compliance Audits
  • Foreign Supplier Verification Program (FSVP) compliance audits
  • Supplier risk assessments
  • Supplier preventive controls audits
• With FSMA, the food industry is shifting to a proactive culture that focuses on preventing contamination events, rather than reacting after the fact. CDG can help you ensure compliance across your food facilities and supply chain with FSMA audit, testing, training and technical services.

The FDA Food Safety Modernization Act (FSMA) is transforming the nation's food safety system by shifting the focus from responding to foodborne illness to preventing it.

The FDA FSMA rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals is final, and the first compliance dates begin May 30, 2017. ... The FDA is committed to helping importers the FSVP requirements.

The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on Jan. 4, enables FDA to better protect public health by strengthening the food safety system. It recognizes that preventive control standards improve food safety only to the extent that producers and processors comply with them.
Achieve certification and help prepare your organization for FSMA compliance.

Service Details:

CDG is a FDA-regulatory compliance company specialized in helping non-U.S. based companies in the food, beverage, dietary supplement, drug and medical device industries who sell their products into the United States. Under U.S. law, foreign-based food, drug and medical device companies are required to register with the FDA and appoint a "U.S. Agent".We are committed to helping foreign-based companies with their FDA registration questions and issues, and focus our expertise and services EXCLUSIVELY on clients located outside the United States. We maintain legal and regulatory consultants on staff to provide our clients with critical information and updates on FDA activity, the Food Safety Modernization Act, and other relevant U.S. food, drug and medical device regulations.

FDA Food Registration (Bioterrorism Act) is required for both domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States. The owner, operator, or agent in charge of a facility, or an individual authorized by one of them, may register that facility.

Our Services:

• All the Regulatory Registration functions of the Departments of the Indian FDA - CDSCO & NPPA.
• The overseas FDA Product Registrations in the major Export destinations of india. The facilitation of an entire range of Clinical Testing studies required for any FDA registration in india and abroad. Food products rank among the most heavily regulated goods in U.S. commerce. All food imported into the U.S. must meet the same requirements for food safety and food labeling as food produced within U.S. borders. These requirements are very complex. U.S. Food Imports shoulders the burden of navigating complex FDA requirements so you don’t have to.
• For foreign companies importing into the United States, a U.S. registration agent is required. A registered agent acts as a registered address of the corporation in the U.S. and provides this registered address for the receipt of service of government filings – and sometimes legal documents - and acts as a liaison for government agencies.

Service Details:

We are a leading organization of the industry, dedicatedly engaged in offering an optimum quality array of FDA Certification Services for our esteemed customers. We help companies to achieve US FDA registration for exporting their products to the USA. Our service is rendered by our talented professionals as per the industry quality standards.   
 
Other Details:

• Flexible approach
• Use advanced tools and technologies
• Crystal clear dealings
• Timely executed