The U.S. Customs and Border Protection (CBP or Customs) works in conjunction with the Food and Drug Administration (FDA) to ensure that products are in full compliance before they are imported or exported to and from the United States. At times, the FDA or Customs may deny the entry of a product if they determine that a good or product fails to meet strict import/export requirements. When this happens, the product is detained for further examination. Depending on the findings of the examination, the FDA may issue a Notice of Action. The U.S. Food and Drug Administration (FDA) is responsible for regulating and enforcing laws related to the safety and efficacy of food, drugs, and medical devices. In the event that the FDA has concerns about a product, it may issue a Notice of Action (NOA) to the manufacturer or distributor of the product. In this blog, we will discuss what an FDA Notice of Action is and how an experienced attorney like CustomsESQ/Abady Law Firm P.C. can help you respond.
What is an FDA Notice of Action?
Regulated products must comply with the FDA’s Food, Drug and Cosmetic Act. Any products entering U.S. customs that are found to be or are suspected of being non-compliant are detained for further physical examination. The FDA district office then issues a “Notice of FDA Action.” This notice specifies the nature of the violation and gives the consignee or owner of the product an opportunity to respond and provide evidence as to the admissibility of the product. An FDA Notice of Action is a written communication from the FDA to a manufacturer or distributor of a product, which expresses concerns about the safety, efficacy, or regulatory compliance of the product. The NOA may request additional information or documentation, or it may impose certain requirements or restrictions on the product. The issuance of an NOA can have serious consequences for a company’s reputation, finances, and market position, which is why it’s important to respond promptly and effectively.
If you have a good or product that is detained in Customs, plan to import a product and need information on importing requirements and procedures, or you simply need assistance obtaining import documentation, contact a Customs law firm right away.
Don’t wait until your product is tied up in bureaucracy or sitting in an FDA detention center. An import and export attorney will work diligently to make sure your product is in full compliance with all FDA and international requirements to the mutual satisfaction of all parties involved.
For more information about an FDA notice of action or for assistance with any of the issues noted above, contact Abady Law Firm, P.C., at 800.549.5099, to speak with a customs law attorney.
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Some industrial segments need to be exponentially stringent with their quality and compliance processes compared to other segments.
The Life Science industry is part of this stringent segment.
They need to ensure the quality of their products because they deal with human safety.
The accuracy and efficiency of their work could well be a matter of life and death.
