An import alert is a notification from FDA to its field staff and public that the agency has substantial evidence on products that appear to be in violation of FDA regulations and that all future shipments of the such products are subject to Detention Without Physical Examination (DWPE) at the port of entry. These violations could be related to the product, manufacturer, shipper etc. Some examples of violations that may trigger import alerts are:
- Product appears to be adulterated
- Product appears to be misbranded
- Manufactured, processed, or packed under insanitary conditions
- The product is unapproved new drug
- Foreign firm has refused FDA inspection
- Forbidden or restricted for sale in the country in which it was produced or from which it was exported
Types of import alerts:
- Country- or area-wide
- Manufacturer/Product Specific
- Shipper
- Country/World Wide Alert
When FDA issues an import alert it is added to the red list. When the firms, products or countries have met the criteria for exemption from DWPE, they are added to green list. The firms, products or countries that are subject to intense surveillance or additional analyses are added to yellow list.
Every importer should check if the products being imported are subject to DWPE or not. Once a shipment is refused admission to the U.S., the importer has an opportunity to provide evidence to overcome the appearance of a violation. Such imported product, firm or country may remain in this status until FDA is convinced that the conditions to apparent violations have been resolved and that future entries will be FDA compliant.
Individual Import Alerts may include specific information regarding removal from DWPE. You should review the import alert specific to your alert and submit any and all documentation called for. You can access FDA’s Import Alerts here. FDA notifies the responsible parties that an imported product violates FDA regulations by issuing a Notice of Detention and Hearing. The notice provides a Respond By date to provide FDA with evidence to overcome the appearance of a violation.
Firms can seek expert guidance to make sure their product ingredients are approved and the labels are truthful and compliant with FDA regulations.
Liberty Management Group LTD is one of the leading FDA consulting groups in USA. LMG provides guidance with FDA registrations, label and ingredient compliance, and many more FDA regulations.
Namrata
FDA Regulatory Consultant
support@libertymanagement.us
Published on March 06, 2019