FDA Detention & Import Refusal

FDA detains imported food, drug, cosmetic, and device shipments that violate FDA regulations. LMG helps manufacturers avoid FDA detention and resolve import refusal notices.

Avoid FDA DetentionResolve Import RefusalAll Product TypesSince 2009

What is FDA Detention?

FDA Detention occurs when FDA refuses entry of imported products into the United States due to regulatory violations. Detained products are held at the port of entry and may not be released until compliance is demonstrated or the shipment is exported/destroyed.

The most common reasons for FDA detention include: unregistered foreign establishment, lapsed FDA registration, labeling violations, adulteration, and import alert.

An Import Alert is placed by FDA on specific products or establishments that have a history of violations. Products subject to an import alert are detained automatically (“detained without physical examination”) until the alert is lifted.

LMG assists manufacturers in resolving FDA detention and import refusal by identifying the root cause, correcting compliance issues, and working toward release or removal from import alert.

Unregistered facility — register with FDA immediately
Lapsed registration — renew or restore registration
Labeling violations — correct labels and submit corrected labeling
Adulteration — address manufacturing or contamination issues
Import alert — submit evidence of corrective actions to FDA

Liberty Management Group Ltd. assists exporters and importers in releasing detained products by bringing them into compliance with FDA regulations.

FDA Detention of Medical Device

The most common reasons FDA detain a medical device are

The manufacturer is not registered with FDA
The manufacturer doesn’t have a US Agent
The exporter is not registered with FDA
The importer is not registered with FDA
The medical device is not listed with FDA
The medical device labeling is not complying with FDA regulations
The medical device doesn’t have 510(K) clearance or PMA

FDA Detention of Food products

The most common reasons FDA detain Food products

The food establishment is not registered with FDA
The manufacturer doesn’t have a US Agent
The prior notice is not issued
The food labeling is not complying with FDA regulations
The food is adulterated, misbranded or filthy

FDA Detention of OTC Drugs and API’s

The most common reasons FDA detain OTC Drugs and API’s

The drug establishment is not registered with FDA
The manufacturer doesn’t have a US Agent
The drug products are not listed with FDA
The drug doesn’t follow OTC Monograph
OTC drugs / API’s doesn’t have proper labeling

FDA Detention of Cosmetics

The most common reasons FDA detain Cosmetics

The cosmetic establishment is not registered with FDA
The manufacturer doesn’t have a US Agent
The cosmetic products are not listed with FDA
The cosmetics contain unsafe colors
The cosmetics contain a poisonous or deleterious substance
The cosmetic labeling doesn’t comply with FDA requirements

Frequently Asked Questions

Common questions about FDA detention.

How do I know if my products are detained by FDA?

You will receive an FDA Notice of Refusal. You can also check the FDA OASIS system to verify if your establishment is on import alert.

Can detained products be released?

Yes. Detained products may be released if you can demonstrate compliance through documentation, relabeling, reconditioning, or other corrective actions.

What is an FDA Import Alert?

An Import Alert (IA) is an FDA alert that causes products from a specific establishment or country to be automatically detained. Removal from import alert requires demonstrating consistent compliance.

How does LMG help with FDA detention?

LMG helps identify the cause of detention, corrects registration or labeling issues, and assists in preparing documentation to support release of detained products.