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The establishment registration needs to be renewed every year and needs to submit a “no change” certification if there is no change in drug listing.
Obligation to renew the registration during the open period October to December. The product of an establishment not renewed by December 31 will be deemed as misbranded and subject to regulatory action. For the listing, it will be needed to submit a no change certification every year during the renewal period. As per the 2016 new rule, any product listing that is not certified as required may be considered inactive and will be removed from the NDC directory and other publications of listing data.
TABS can issue a company certificate of FDA registration to confirm that the facility has been successfully registered at the FDA Food Facility Registration for the current period.
TABS will assist you with the compliance to send your wine samples for soliciting orders or trade shows.
The TTB requires the label of alcoholic beverages to be approved before entering the market or COLA. For tasting samples, they allow requesting a waiver.
TABS will help you to get your COLA waiver fast and easily. Pricing starts at $150 per submittal, contact us for an estimate for the logistics and shipping of your samples.
TABS specialists will help you to assess the compliance requirements of your product.
Schedule a consultation with us to learn the requirements for your FDA registration. We will provide you with the materials and guidance needed to start introducing your products in the US.
This is a conference call of ½ hour and includes an email follow-up with the appropriate guidance adapted to your product/needs.
Cosmetics marketed in the United States, whether they are manufactured here or are imported from abroad, must comply with the labeling requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act and the Fair Packaging and Labeling (FP&L) Act.
Label review is important: Depending on the claims made, some cosmetic products may also be drugs. If a cosmetic product is also a drug, it must comply with the requirements for both cosmetics and drugs.
TABS will assist you to understand and comply. We will schedule a 30 mins. call to identify your needs.
Label review is important, for instance, depending on the claims made, some cosmetic products may also be drugs. TABS will help you to comply.
Cosmetics marketed in the United States, whether they are manufactured here or are imported from abroad, must comply with the labeling requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act and the Fair Packaging and Labeling (FP&L) Act.
TABS will give you a basic review and assessment of your label. Further assistance will be quoted case by case.
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of the FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938.
This new law will help ensure the safety of cosmetic products many consumers use daily.
Please book a consultation call to find out more about the new law and how can TABS assist you.
Create a FURLS account (FDA Unified Registration and Listing System) in the FIS (FDA Industry System) and link to your FDA facility registration.
TABS will assist you to understand and comply with Drugs products compliance requirements for your facility and products.
We will schedule a 30 mins. call to identify your needs.
This is an FDA requirement beginning October 1st, 2020. TABS will apply for your DUNS number on your behalf.
Beginning October 1, 2020, the facility’s UFI recognized as acceptable by FDA will be required to be submitted with the registration information (21 CFR 1.232(a)(2)). At this time, FDA recognizes the Data Universal Numbering System D-U-N-S (DUNS) number as an acceptable UFI. DUNS numbers are assigned and managed by Dun & Bradstreet.
Food Facility Registration and U.S.-Agent service for foreign companies that are engaged in producing, packing, or holding animal food.
A foreign facility that is engaged in manufacturing/processing, packing, or holding of food for animal consumption in the United States, you must register with the FDA and you must name a local U.S.-agent for communications purposes. If you are the owner, operator, or agent in charge of a facility, you can authorize TABS specialists to register your facility on your behalf.
This is a bi-annual fee.
If your process acidified or low acid foods in your facility, you need to register your facility as FCE and file your processes in the LACF system.
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).
TABS will register your FCE. This is a one-time fee.
Food Facility Registration and Agent Service for foreign companies that are engaged in producing, packing, or holding food for human consumption.
As a foreign facility that is engaged in manufacturing/processing, packing, or holding of food for human consumption in the United States, you must register with the FDA and must name a local US agent for communications purposes. If you are the owner, operator, or agent in charge of a facility, you can authorize TABS specialists to register your facility on your behalf.
This is a bi-annual fee.
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.
