Did the FDA stop your import and issue an FDA Notice of Action?
10Days
Typically the “respond by” date is 10 business days but can be up to 20 calendar days to allow for weekends, holidays, and mailing time. If not received a refusal of admission can be issued.
100K
Over one hundred thousand companies import products a year. To ensure no complications they rely on the best compliance attorneys to assist.
Did the FDA stop your import and issue an FDA Notice of Action?
10Days
Typically the “respond by” date is 10 business days but can be up to 20 calendar days to allow for weekends, holidays, and mailing time.
100K
Over one hundred thousand companies import products a year. To ensure no complications they rely on the best compliance attorneys to assist.
Need more time to respond
You may request an extension within the specified timeframe
My product is detained
Submitting evidence or request to recondition to correct the violation.
Notice of Detention and Hearing
The sections of the laws and regulations that appear to be violated; these are referred to as charges.
Detention Without Physical Examination
For a private lab report to be completed, you may send a request for extension
Immediate FDA Assistance
If so, time is of the essence to have the product released before FDA requires you to export or destroy
" The FDA (Food and Drug Administration) works alongside CBP (Customs and Border Protection) to hold regulated imports and check their compliance by testing, sampling, or conducting a more thorough review.
An FDA Notice of Action may be issued for a number of reasons including:
Misbranding (Labeling Issues)
When labeling is an issue there are options to have the shipment released based on adjusting the label (also called reconditioning). The content on product labeling should be reviewed prior to import to avoid issues.
Adulteration (Filth, rodent, insects)
When a shipment is adulterated, it means that it contains something that may render it injurious to the health of consumers. When a shipment is found to be adulterated, it will be held and exported unless a petition is submitted to counter that conclusion by the agency.
Samples outside allowable limits
The FDA may hold a shipment for sampling and testing to determine if the products meet public health standards. There are methods for countering the FDA’s conclusions when testing a product imported into the U.S.
Non-Permitted food and color additives
The FDA regulates the use of additives in ingestible products in the United States. Making sure the food or colors additives in a product are essential to marketing and selling that product in the U.S.
Find out how we can help you
We strive to ensure that our clients are educated about the processes of becoming compliant and understand our role in the process. Hiring an FDA regulatory attorney can make all the difference when ensuring compliance.
Let us provide you a free consultation on us today ($99 value)