Tag: FDA Food Facility Registration

DUNS NUMBER

A DUN’S number is a unique nine-digit identifier assigned by Dun & Bradstreet (D&B), a business credit bureau. The DUNS Number is location specific. So, each physical location of an entity such as branches, divisions, and headquarters may be assigned a DUN’S number separately.

To market food, drugs and medical devices products in the United States, companies must have DUNS number.

Food: All domestic and foreign food facilities what wants to sell their food products in the US will be required to provide a Unique Facility Identifier (UFI) when registering with FDA or renewing food facility registration with FDA. DUNS number is the only acceptable UFI recognized by FDA.

For new registrations – Once the registration is submitted, FDA will verify the accuracy of UFI. FDA will not confirm the registration or provide a registration number until verification is complete.

For biennial renewals – Once the renewal is submitted, FDA will verify the accuracy of UFI. FDA will not confirm the renewal until verification is complete.

Drugs: US FDA will directly pull the company information only from FDA’s DUNS portal. So, companies who want to register with FDA must obtain DUNS first and then proceed with registration.

Medical Devices: Even though for now, DUNS number is not mandatory to register, to submit Unique Device Identification (UDI), DUNS is a mandatory requirement.

DUNS number for FDA purposes is free of cost. Facilities registering with FDA must obtain a DUN’S number first. DUNS requests may take up to 30 days.

Liberty Management Group, as leading FDA consultant provide assistance with DUNS number lookup and FDA registration and renewals.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

LABEL COMPLIANCE

FDA labeling compliance requirements vary for each product. In general, information on the label must be truthful and not misleading, labels should include all the required information for the product category, wording and formatting should be easy for consumers to understand.

Below are basic requirements for each product category.

Food

  • Ingredient list
  • Nutrition information panel
  • Allergen warnings
  • Name and address of the manufacturer.
  • Net quantity of contents

Medical Devices

  • Intended use of the device
  • Directions for use
  • Warnings and precautions
  • Sterilization information (if applicable)
  • Manufacturer information

Drugs

  • Drug facts table.
  • Intended use of the drug with active ingredients concentration.
  • Warnings and precautions.
  • Directions of use
  • Inactive ingredients
  • Manufacturer information
  • Expiration date

Cosmetics

  • Principal Display Panel (PDP)
  • Product Name
  • Identity Statement
  • Net quantity and Ingredient list
  • Warning and Precautions

The FDA provides comprehensive guidance documents to help navigate the complexities of labeling compliance.

The FDA does not pre-approve labels, so manufacturers are responsible for ensuring compliance.

Liberty management Group, LTD as a leading FDA consulting firm provides assistance with Food, Drug, Medical devices and Cosmetics labeling compliance.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

U.S AGENT

Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a food, drug, medical device, and cosmetics imported into the United States must identify a U.S. agent for that establishment.

Information about a foreign establishment’s U.S. Agent must be electronically using the FDA FURLS system or CDER/ESG and is part of the establishment registration process. Each foreign establishment may designate only one U.S. agent. The foreign establishment should provide the name, address, telephone, and e-mail address of the U.S. agent.

Responsibilities of a U.S. agent

The U.S. agent must either reside in the U.S. or maintain a place of business in the U.S and they cannot use P.O. BOX as the address. U.S agents must be available to answer the phone or have an employee available to answer the phone during normal business hours.

The responsibilities of the U.S. agent are limited and include:

  • Assisting FDA in communications with the foreign establishment, meaning that function as a mediator between the client and the FDA.
  • Responding to questions concerning the foreign establishment’s products that are imported or offered for import into the United States,
  • Assisting FDA in scheduling inspections of the foreign establishment and
  • If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be equivalent to providing the same information or documents to the foreign establishment.

Liberty Management Group, a leading FDA consulting firm provides assistance with US agent services all foreign food, drug, medical devices and cosmetics establishments.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

WHO NEEDS TO REGISTER WITH FDA?

The US Food and Drug Administration (FDA) is responsible for protecting public health by ensuring the safety, efficacy, and security of human and animal drugs, biological products, medical devices, food (including animal food), cosmetics, and tobacco products. It also regulates electronic products that emit radiation.

Foods:

The FDA regulates the safety, labeling, and quality of all other food products except for meat, poultry, and egg products, which are regulated by the US Department of Agriculture (USDA).

In general, it includes Fresh and processed foods, Dietary supplements, Bottled water, Food additives, Infant formulas, fruits, and vegetables.

Drugs:

The FDA regulates the safety, effectiveness, and quality of all human and animal drugs, which includes prescription and over-the-counter drugs, homeopathic drugs, active pharmaceutical ingredients and vaccines and other biological products.

Medical Devices:

The FDA regulates the safety, effectiveness, and quality of all medical devices used in humans which includes a wide range of devices, from simple bandages to complex surgical implants.

Cosmetics:

The FDA regulates the safety of all cosmetics, including makeup, skincare products, and hair care products, Hair care products, lotions, and moisturizers.

Products are categorized based on the label claims and regulated according to intended use.

Liberty Management Group Ltd, as a leading FDA consulting firm providing assistance with FDA registration of food, drug, medical devices and cosmetic products.

Liberty Management Group Ltd, as a leading FDA consulting firm will provide assistance with above all regulatory requirements.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.ushttp://www.fdahelp.us