FDAeasy.com is a private FDA regulatory consulting service powered by ACI Advisory Group, Inc. and does not represent the U.S. FDA (Food and Drug Administration).

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Detention & Refusal

Your product may be detained because it appears to be:

  • adulterated, meaning the product is contaminated, is not safe, or does not otherwise meet applicable standards;

  • misbranded, meaning the labels contain false or misleading information;

  • an unapproved new drug;

  • manufactured, processed, or packed under insanitary conditions;

  • forbidden or restricted for sale in the country in which it was produced or from which it was exported.

When products in your shipment violate or appear to violate FDA laws and regulations, FDA may detain your product and issue a Notice of FDA Action with the designation of “Detained.”   This notice is considered the Notice of Detention and Hearing.

The “respond by” date is the amount of time to provide testimony.  FDA’s Regulatory Procedures Manual allows 10 business days from the date of detention. To allow for weekends, holidays, and mailing time the Notice of FDA Action generally specifies a timeframe of 20 calendar days following the date of detention shown on the notice.

If the FDA does not receive a response to the detention within the specified timeframe, the compliance officer can issue a refusal of admission.

When importers encounter a detention notice from the FDA

on their imported goods, they often assume the FDA’s reasoning for detaining their goods is correct. Here at FDAEasy.com, we never take any FDA decision for granted. Our determination, along with our expertise, consequentially allows us to obtain the release on most of the FDA detained shipments. With several decades of experience with FDA issues, FDAEasy.com has achieved many FDA releases and releases with comments, despite the facts being different in every case.

Withdrawal of an FDA import refusal

is significantly more difficult. According to the FDA’s policy, a refusal should be understood as a “final action” and can be withdrawn only when the FDA made a mistake in processing the case’s entry. FDAEasy.com utilizes these frequent errors, including when FDA’s interpretation of the law or the logic is wrong, or when they make a decision based on inaccurate facts or through incorrect procedures. In these cases, the most crucial thing to do is to identify the errors and contact the FDA as soon as possible. When FDAEasy.com is appealing against an import refusal, we don’t just stop if the compliance officers refuse to admit their mistake, but instead we persist and bring the evidence of the errors based on the law and regulations to the attention of the appropriate senior officials, resulting in a higher chance of obtaining a withdrawal of the FDA import refusal.

Timeliness is crucial. Please keep in mind that the longer the detention is neglected, the likelihood of obtaining the release of your products also decrease remarkably.

FDAeasy.com is a consulting firm with specialized FDA consultants and affiliated FDA attorneys, who have extensive experience with FDA import detentions and import refusals. FDAeasy.com would gladly help you learn the requirements you need to prepare to prevent business loss emerging from an FDA detention or refusal. When you work with the right people with the right know-how, you will see how easily the process works for you. ­

Contact us today to learn more.