A company may submit a written petition to FDA to remove its products from the Red List of an Import Alert. The petition should describe how the company identified the source of the problem and how it is implementing corrective actions that will prevent future violations. In addition, the company typically has to present to FDA at least five consecutive shipments that are free of any violations of the FFDCA (“clean shipments”). Other supporting evidence of compliance may include monitoring records, revised standard operating procedures (SOPs), third party audit reports, etc.

Common mistakes and problems that may result in the failure of an Import Alert petition:

• Corrective action plan is inadequate – In the past, simply presenting five clean shipments to FDA was often sufficient for removing a company from a Red List. However, FDA now usually requires an Import Alert petition to detail the measures taken to resolve the conditions that led to the violation
• Shipments are too small – A company may not simply ship a small sample or split one commercial shipment into several smaller shipments to meet the five clean shipment criteria for Import Alert petitions. FDA has not formally established a “minimum size” for the shipments but as a rule of thumb, FDA considers a shipment to be of commercial-size if it has a value of $2,500.00 USD or more (the value at which Customs requires a shipment to be covered by an entry bond as a “formal entry”).
• Shipments are not consecutively released after detention – For example, if FDA releases three shipments after detention but refuses admission of the fourth shipment for any violation, then the company must start over with five new, clean shipments. A shipment (delivered to any importer) containing any violation of the FFDCA may break the chain of consecutive shipments.
• Shipments are not adequately spaced apart – To support Import Alert petitions, the shipments must be “routine, commercial” shipments that demonstrate successful corrective action over an adequate period of time. Therefore, the shipments should be adequately spaced apart. FDA has not established any specific timeframes for spacing apart the shipments but requires that the shipments occur at a “reasonable” frequency to sufficiently demonstrate that the conditions that led to the violations have been resolved.
• FDA does not detain a shipment before releasing it – FDA must detain the shipment if the company wishes to use it as evidence to support an Import Alert petition. This may initially seem counterintuitive, but FDA requires detention of those entries so that the agency is assured that any evidence of compliance the importer submits to FDA as testimony is specifically tied to the goods held under detention. For example, if the importer submits private lab testimony to FDA, FDA needs the goods held intact to ensure that the sample is derived from the merchandise they detained.
  • However, FDA will sometimes inadvertently release shipments of products that are on an Import Alert Red List without first detaining it, resulting in the company losing the opportunity to use that shipment as evidence to support an Import Alert petition. So a foreign company petitioning FDA to remove its products from an Import Alert should ensure that all its US importers are checking to make sure that FDA is detaining the shipments before releasing them if the company wishes to use those shipments to support its Import Alert petition.