FDA Compliance
Food and Drug Administration
FDA Registration can be complex. We make it easy.
The U.S. Food and Drug Administration (FDA) is responsible for protecting public health by regulating imported products. Any company that plans to distribute food, animal, medical, or beauty products for the U.S. market is required to register with FDA.
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— FDA CONSULTING
You focus on your business. We’ll focus on compliance.
Our regulatory specialists can complete your required facility registrations quickly and efficiently.
We list our prices up front so you never have to guess how much you’ll pay.
Every year, 30,000+ clients around the world trust our regulatory specialists to safeguard their companies.
If you produce products in the categories below, FDA registration must be mandatory:
Each product category has specific exemptions and SAB Group can help you determine whether you must register your facility.
Food and Beverage
Food compliance is our specialty. We offer cost-effective facility registration and renewal, DUNS number assistance, U.S. Agent representation, Prior Notice support, Mock FDA and FSVP inspections.
Cosmetics
Sab Group makes MoCRA FDA compliance quick and easy. We can help you with facility registration, act as your U.S. agent if you’re located outside the U.S., submit and manage product listings, and act as your adverse event contact.
Drug Products
Bring safe and compliant drugs to market. Our services for drug establishments include annual facility registration and renewal, DUNS number assistance, U.S. Agent representation, and product listing submissions.
Medical Devices
Most medical devices have to meet substantial, complex regulations. We can help with facility annual registration and renewal, UDI and GUDID device compliance, U.S. Agent representation, and electronic medical device reporting (eMDR).
Animal and Veterinary
Food compliance is our specialty. We offer cost-effective facility registration and renewal, DUNS number assistance, U.S. Agent representation, Prior Notice support, Mock FDA and FSVP inspections.
Tobacco Products
Sab Group makes MoCRA FDA compliance quick and easy. We can help you with facility registration, act as your U.S. agent if you’re located outside the U.S., submit and manage product listings, and act as your adverse event contact.
Radiation-emitting devices
Bring safe and compliant drugs to market. Our services for drug establishments include annual facility registration and renewal, DUNS number assistance, U.S. Agent representation, and product listing submissions.
Biologics
Most medical devices have to meet substantial, complex regulations. We can help with facility annual registration and renewal, UDI and GUDID device compliance, U.S. Agent representation, and electronic medical device reporting (eMDR).
FDA Registration made easy.
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What we do
Certificate of Registration
Once a company is registered, FDA issues registration numbers but does not provide Certificates of Registration. Yet many buyers or importers still request registration confirmation from their suppliers.
If your facility has already registered with FDA, SAB Group can provide a third-party Certificate of Registration to serve as confirmation of your valid FDA registration to buyers, customs brokers, and suppliers. We currently offer third-party Certificates of Registration for companies in the food and beverage, drug, and cosmetics industries.
If your facility is not registered with FDA, consider working with SAB Group to register your facility and obtain a third-party Certificate of Registration.
Verify Your FDA Registration
FDA registration numbers can become invalid unexpectedly and cause delays or detentions at ports of entry. Reasons your FDA registration number may be invalidated include:
Outdated ownership or other information
Registration not submitted by authorized person
Facility’s U.S. Agent refusing the designation
Registration not renewed before renewal deadline
At SAB Group, we provide U.S. FDA registration verification at no additional cost. You can quickly and easily check whether your facility’s registration is valid and take corrective action to prevent potential fees or fines.
Verify Your FDA Registration
FDA registration numbers can become invalid unexpectedly and cause delays or detentions at ports of entry. Reasons your FDA registration number may be invalidated include:
Outdated ownership or other information
Registration not submitted by authorized person
Facility’s U.S. Agent refusing the designation
Registration not renewed before renewal deadline
At SAB Group, we provide U.S. FDA registration verification at no additional cost. You can quickly and easily check whether your facility’s registration is valid and take corrective action to prevent potential fees or fines.
What we do
Affirmation of Compliance
When a product arrives at a U.S. port of entry, certain information must be provided and transmitted electronically to the United States Customs and Border Protection (CBP). If the product is or may be regulated by FDA, CBP sends the import entry information to the FDA for verification.
Appropriate Affirmation of Compliance (AofC) codes and qualifiers can expedite the admissibility process. While the use of these AofC codes is voluntary, it will help expedite the entry review process and increase the likelihood that the shipment may be processed based on import system screening.
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