FDA makes mistakes just like everyone else, so don’t assume that FDA is always right. We experienced a case where FDA placed the wrong firm on Import Alert 86-07 (“Detention without Physical Examination of and Guidance of Impact-Resistant Lenses in Eyeglasses and Sunglasses.”) FDAImports.com successfully assisted our Chinese client with obtaining removal from this Import Alert.
FDA’s Mistake Can Hurt Your Business
When FDA places a firm’s product on import alert, it will automatically stop all shipments of the product and require the U.S. importer to prove that the product complies with the law, which may require laboratory testing. If the importer fails to do so, FDA will refuse to allow the product into the United States. This process is time-consuming and expensive; the import delays can damage business relationships.
In this case, FDA placed the Chinese manufacturer on import alert because glasses that it never manufactured failed FDA testing. FDA wrongly believed the company made the non-compliant glasses because it was falsely declared as the manufacturer on the commercial documents and the proper device listing number was provided. Unfortunately, FDA did not aggressively question the veracity of the manufacturer claim.
We analyzed the commercial documents from the non-compliant shipment and determined that they were, on their face, false: they even spelled the name of the company wrong. We presented this evidence to FDA, which recognized its mistake and removed the company from import alert.
Unfortunately for the Chinese company, it had already experienced import delays and damaged relationships with its importers.
Protect your device listing number!
This case highlights the importance of foreign manufacturers needing to monitor FDA’s import alerts to verify that FDA does not mistakenly place them onto an import alert. If a manufacturer finds out because FDA started stopping its shipments, it is already too late and it will begin experiencing delays and additional costs. If your company is on this Import Alert, contact us to review your case!
For device manufacturers, this case highlights the importance to guard their device listing numbers. FDA uses this number to verify whether the goods are legitimate. A device listing number is a company’s proprietary information, and should not be widely shared.
