Is FDA Detention Interrupting Your Supply Chain?
Whether it is your first or hundredth time importing food to the US market, receiving an FDA Detention Notice can cause unwanted challenges and dread. Detentions can result in delays to market, increased expenses in warehouse storage, and frustrated buyers with orders that fall short of expectation and delivery. This can be costly in both reputation and dollars.
The US FDA works hard to protect US consumers and their food supply. The Federal Food, Drug, and Cosmetic Act grants the FDA authorization to detain shipments that they suspect violate the act. The FDA can collect samples to analyze themselves or detain a shipment without physical examination (DWPE) if the manufacturer is red-listed under an import alert.
If the shipment is detained under DWPE, the manufacturer is issued a notice of action, which provides a detailed explanation for why the entry is detained, the due date for a response, and the compliance officer assigned to the entry. Manufacturers can have a 3rd party testing laboratory collect samples for analytical testing. Labs will prepare a private laboratory analytical package to submit as evidence and testimony to the FDA for review. After a thorough review of the results and lab package, an FDA compliance officer will determine whether the product can be released into US commerce or if it will be refused entry.
This Is Where Mérieux NutriSciences Can Help!
As an independent 3rd party laboratory with decades of FDA detention experience, Mérieux NutriSciences makes this process as easy as ABC for importers!
A: Send us the entry documents, including the Notice of Action, Bill of Lading, Customs Form, Commercial Invoice, Packing List, and Warehouse location. We will send back an all-inclusive quote to resolve the detention.
B: Approve the quote and let us do the rest! We schedule the sampling from the warehouse, ship samples to the lab, complete the analysis, and prepare the private laboratory analytical packet.
C: When testing completes, the importer reviews the COA and completes an importer’s statement. We upload the analytical packet to the FDA via ITACS for their review and ruling.
D: We offer onsite consultancy to help importers with preventive controls to minimize the likelihood of import detention.
That’s It!
Our dedicated FDA Detention team has successfully submitted thousands of private lab packages to the FDA, so we understand the frustration and costs associated with the delays caused by detentions. Let our experienced and detailed team resolve your detention quickly and keep your supply chain moving.