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The FDA Food Safety Modernization Act of 2011 mandates the creation of a food safety system.
The FSMA rules include those that require preventive controls for food facilities that manufacture/process, pack and hold human and animal foods and establish science-based standards for produce grown on farms.
These rules apply to domestic food producers and those in other countries who export to the United States.
TABS will assist you to understand and comply with Food Safety compliance requirements for your facility. We will schedule a 30 mins. call to identify your needs.
The FDA Food Safety Modernization Act of 2011 mandates the creation of a food safety system.
The FSMA rules include those that require preventive controls for food facilities that manufacture/process, pack and hold human and animal foods and establish science-based standards for produce grown on farms.
These rules apply to domestic food producers and those in other countries who export to the United States.
TABS will assist you to understand and comply with Food Safety compliance requirements for your facility. We will schedule a 30 mins. call to identify your needs.
FSVP importers are required to develop, maintain and follow an FSVP for each food imported unless an exemption applies. TABS can help you to comply.
The FSVP rule requires FSVP importers to verify that the food they import meets U.S. safety standards. FSVP importers are required to develop, maintain and follow an FSVP for each food imported unless an exemption applies.
TABS specialists can assist importers of food & beverage to meet the FSVP requirements. Pricing starts at $ 800, contact us for a quote.
TABS will assist you to understand and comply with FSVP compliance requirements as an importer.
We will schedule a 30 mins. call to identify your needs.
TABS will assist you to understand and comply with FSVP compliance requirements as an importer.
We will schedule a 30 mins. call to identify your needs.
For trade fairs it is necessary to comply with the requirements for importers imposed by the FDA in order to enter the U.S. market.
The FSVP rule requires FSVP importers to verify that the food they import meets U.S. safety standards. FSVP importers are required to develop, maintain and follow an FSVP for each food imported unless an exemption applies.
TABS can help you to comply and meet the FSVP requirements.
FSVP importers are required to develop, maintain and follow an FSVP for each food imported unless an exemption applies. TABS can help you to comply.
The FSVP rule requires FSVP importers to verify that the food they import meets U.S. safety standards. FSVP importers are required to develop, maintain and follow an FSVP for each food imported unless an exemption applies.
TABS specialists can assist importers of food & beverage to meet the FSVP requirements. Pricing starts at $ 800, contact us for a quote.
Food ingredients including color additives are regulated by the FDA. If your product does not meet the requirements your product could be deemed adulterated or misleading.
TABS specialists will help you to assess the compliance of the ingredients, additives, and color additives of your product. Schedule a consultation with us.
TABS will give you a BASIC review and assessment of your label. Further assistance will be quoted case by case.
Manufacturers of drugs to be imported in the U.S. need to register with the FDA and list the drugs. TABS can assist you to comply.
The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA. These domestic and foreign firms must, at the time of registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S. Additionally, foreign establishments must identify a U.S.-agent and importers at the time of registration.
Animal food label and ingredients including color additives are regulated by the FDA. If your product does not meet the requirements your product could be deemed adulterated or misleading.
Foods sold in the United States need to be properly labeled. It is recommended that manufacturers and importers become fully informed about the applicable laws and regulations regarding the label of animal food before offering them for distribution in the United States.
TABS will give you a basic review and assessment of your label. Further assistance will be quoted case by case.
Label compliance is an important aspect of doing business in the U.S. If your product does not meet the requirements your product could be deemed mislabeled or misleading.
All Foods sold in the United States need to be properly labeled. It is recommended that manufacturers and importers become fully informed about the applicable laws and regulations regarding the label of food and dietary supplements before offering them for distribution in the United States.
TABS will give you a basic review and assessment of your label. Further assistance will be quoted case by case.
TABS can assist you in determining if a product is regulated by the FDA as a medical device and to confirm the regulatory class that applies to your device.
The FDA regulates the sale of medical device products in the U.S. and monitors the safety of all regulated medical products. TABS can assist you in determining if a product is regulated by the FDA as a medical device and to confirm the regulatory class that applies to your device.
TABS will give you an initial assessment of your classification. Further assistance will be quoted case by case.
Establishments engaged in the manufacturing or other activities of medical devices to be marketed in the US need to register the facility, list the devices and name an agent for communication purposes.
Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States are required to register annually with the FDA. (Title 21 CFR Part 807).
Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a U.S. agent for that establishment.
*FY fee
Establishments engaged in the manufacturing or other activities of medical devices to be marketed in the US need to register the facility, list the devices and name an agent for communication purposes.
Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States are required to register annually with the FDA. (Title 21 CFR Part 807).
Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a U.S. agent for that establishment.
*FY fee
The FDA has labeling requirements for medical devices to be marketed in the U.S.
TABS will give you a basic review and assessment of your label. Further assistance will be quoted case by case.
The Prior Notice has to be filed 2 days prior to the arrival of your samples to the US. We can assist you with the filing.
The Food Act requires that FDA receives the prior notification of food, including animal feed that is imported or offered for import into the United States. It has to be filed in the FIS system 2 days prior to the arrival of your samples to the US. We can assist you with the filing. (21 CFR 1.276 to 1.285). TABS will assist you with your 1st Prior Notice and will guide you through the process so you can file your next prior notices.
