When products in your shipment violate—or appear to violate—FDA laws and regulations, the 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. A recent example is the import hold placed on a shipment of devices from Olympus Medical, with FDA citing "concerns related to outstanding Quality System regulation violations."
Act Quickly to Avoid Delays and Economic Loss
Knowing what to do in response to Notices of Detention and Hearing and reacting quickly can help avoid unnecessary delays and potential economic losses. Lifting such holds often requires quickly assembling information related to the claimed FDA violation that caused the Notice. Providing that information to FDA helps demonstrate that you have addressed its concerns or that the company will remedy the alleged violation.
Delays in responding or incomplete submissions can result in prolonged detentions. Frequently, FDA is simply waiting for this information to move forward.
What to Include in Your Response to FDA
Your response may involve a “hearing,” which serves as an opportunity to present evidence or testimony rebutting the appearance of a violation and assuring FDA that the product is in compliance. A hearing can vary from a series of email or telephone conversations to a more formal submission through the FDA portal.
Often, a “hearing” is the chance to provide evidence to the hearing officer—generally the FDA compliance officer listed on the Notice of Detention and Hearing.
You have the right to provide oral or written testimony to the Food & Drug Administration regarding the admissibility of the article(s) or to propose corrective action so that the article(s) can be brought into compliance. Testimony is information you wish to submit to overcome the appearance of the violation, or to otherwise support the release of your product. Testimony should be provided to the contact, usually a compliance officer, listed in the Notice of FDA Action.
Pursuant to FDA guidance, the owner or consignee may respond to the Notice of FDA Action. FDA also recognizes the importer of record as eligible to provide information to FDA about the shipment.
FDA allows several parties to respond to a Notice of Detention, including:
- The owner of the goods
- The consignee
- The importer of record (which may be a broker, consignee, or owner)
- An authorized representative (with written permission from one of the above
A designated representative of the consignee, owner, or importer of record may appear or respond on the consignee's (importer's) behalf; however, this representative must be authorized in writing by the consignee, owner, or importer.
As David Graham, attorney at Gardner Law, explains:
“The key to resolving an import detention isn’t just understanding the law—it’s knowing how the FDA operates and what information will move the needle. Experience helps ensure your response gets the traction it needs.”
