IMPORT TARIFFS - LATEST NEWS & UPDATES
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When the FDA notices a shipment that potentially violates its import regulations, the shipment is placed on an FDA import alert, and a notice is issued to each US port via its Harmonized Real-Time Alert System. What happens if your freight gets refused entry or detained, resulting in your company being listed on FDA import alert? Working with trusted customs brokers like our team at USA Customs Clearance will help you avoid these pitfalls for a stress-free customs clearance process.
Key Takeaways:
Let’s take a look at what prompts the FDA to impede shipments and how to stay in compliance.
Steer clear of shipping errors that delay the importing process.
Our freight specialists are here to provide you with peace of mind and ensure swift customs clearance.
FDA import alerts come about when a company, product, manufacturer, or country of origin is flagged at the port of entry after discovering a violation. These suspicions arise either because the company, product, etc., has previously violated regulations or appears to be infringing on them at the time of entry.
While the type of violation can vary, usually, FDA import alerts are issued to freight with manufacturing or product errors, such as sanitary violations in the facility where it was made, or the product includes hazardous materials.
Imported goods and documentation are screened electronically for precision. The FDA uses the Nationalized Entry Review Program (NER) to ensure each shipment follows compliance to complete the customs process.
Electronic tools like the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) and System for Entry Review and Import Operations (SERIO+) analyze shipments for the following:
When the products, manufacturer, etc., meet this criterion, an FDA import alert is issued, and the cargo is then placed on hold or seized altogether. Before this takes place, FDA sends a Notice of Action outlining the shipment’s violations, with a Notice of Detention when the shipment is seized.
FDA can hold freight without examination after issuing an import alert. This process is called Detention without Physical Examination (DWPE) and can slow down customs clearance.
When the FDA places a hold on your import, it may or may not stay at the port as they inspect or take samples for testing before proceeding with the customs clearance process.
If it appears your products are adulterated or otherwise hazardous to consumers, FDA may refuse your entry and detain them. In this case, your products may be destroyed under the supervision of the FDA and CBP.
In both incidents, the FDA sends a nationwide import alert and notifies the importer of record or point of contact about the decision. You can search import alerts for existing violations using the FDA database.
Related: FDA Customs Hold: How To Set Your Goods Free From Captivity
While goods that are subject to DWPE appear on FDA import alert, not every alert can be a stain on your business. There are three types of import alerts to be aware of during the import process.
Products, shippers, countries, or manufacturers that appear on the green list are exempt from DWPE. These companies have satisfied Good Manufacturing Practices (GMP) and are clear to proceed in the customs clearance process.
Products, shippers, countries, or manufacturers on the yellow list are not exempt from DWPE but require more surveillance or examination before being released.
Products, shippers, countries, or manufacturers on the red list are subject to DWPE, and a Notice of Action is then escalated to a Notice of Detention that must be responded to within 10 business days.
Related: CBP Clearance Process: A Guide for Importers
Once you’re notified with a Notice of Action that your products are on the import list and are subject to DWPE, here’s what happens next.
First, your Notice of Action will include a letter detailing the potential violation of your product, such as adulterated ingredients or unsanitary conditions at the facility where it was manufactured.
Next, the FDA will perform one of the three inspections that your product violated.
Then, the FDA will proceed with these inspections. There isn’t a specific timeline for the FDA to complete them. However, if the entity deems your products are in violation, they are refused entry and you have 90 days to destroy them under FDA and CBP supervision.
The importer of record or point of contact for a shipper can request to be removed from the red import alert list by submitting a petition for removal.
Your request should include a cover letter, a letter of authorization, and supporting evidence that your product was not in violation of any regulations.
If the FDA accepts this petition and your products pass testing, they will be released and cleared from the red or yellow import list.
When FDA import alerts halt your freight from entry, it can be a costly delay that slows down operations while waiting to sort it out. When you partner with our specialized customs brokers at USA Customs Clearance, we’re dedicated to making your customs clearance process a smooth one.
Call us with your questions at (855) 912-0406 or speak with an expert consultant here.
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