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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
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.
This is a a special package of 10 Prior Notices with a reduced price.
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.
Commercial processors who manufacture, process, or pack acidified foods (AF) and/or thermally processed low-acid foods packaged in hermetically sealed containers (historically referred to as “low-acid canned foods” or “LACF”) must register their facility as FCE (Food Canning Establishment) 21 CFR 108.25(c)(1) (for AF) or 21 CFR 108.35(c)(1) (for LACF). They also need to file the processes 21 CFR 108.25(c)(2) (for processors of AF) or 21 CFR 108.35(c)(2) (for processors of LACF), and submit to FDA iths Schedule Process filings for for all of its commercially sterile, acidified and low-acid canned foods to obtain a Scheduled Process Identification (SID) Number from FDA for each specific canned food and aseptic or acidified food process.
TABS will assist you with the SID filings and registrations.
Food Facility Registration for U.S. companies that are engaged in producing, packing, or holding food.
A domestic facility that is engaged in manufacturing/processing, packing, or holding of food for human or animal consumption in the United States, must register with FDA, whether or not the food from the facility
enters interstate commerce (21 CFR 1.225(b)).
This is a bi-annual fee.
If during the year there are any changes in the existing drug listing, the drug listing should be updated immediately.
Any update outside the 3-month period will require submission for each NDC to certify the product.