How to get off an FDA import alert

For products under DWPE because they appear violative under section 801(a)(3) (adulteration or misbranding), RPM 9-8-15 says a minimum of five consecutive non-violative commercial shipments may be required, in addition to the actions taken to prevent recurrence, and that in some instances more than five may be needed. Other sections give specific numbers:

Some violations need documents rather than shipments. The RPM lists examples such as a proper registration or a scheduled process filing; for low-acid canned and acidified foods, see the NO PROCESS charge.

• Shipments should be routine commercial entries over a reasonable time period that reflect normal shipping patterns.
• Splitting a shipment into several entries or lines does not increase the count; related entries from one lot count as one shipment.
• Shipments of fewer than 10 to 15 cartons that do not reflect normal industry practice may not be considered, unless the product is normally shipped in small quantities.
• If a violative entry is offered while FDA is reviewing the petition, the review may be discontinued until the problem is shown to be corrected.

FDA's FAQ gives an example: a firm that always shipped 100 pails every other week and then sends 5 pails a day during the petition period is not showing routine commercial entries.

1. 01

   Read the alert's Guidance section

   Each import alert says what evidence it expects and where petitions go. FDA's removal page names ImportAlerts2@fda.hhs.gov, with exceptions (such as a division compliance officer) stated in the alert's Guidance section.

2. 02

   Find the root cause

   Document how the violation occurred, for example through a root cause analysis. RPM 9-8-15 says FDA may require one before removal.

3. 03

   Correct and prevent

   Describe the corrective actions taken and the preventive measures now in place, with supporting records.

4. 04

   Build the evidence

   Gather the consecutive non-violative commercial shipments (entry numbers and private laboratory results where relevant), audit reports or other proof that fits the violation.

5. 05

   Send the petition

   Email the complete package. FDA's FAQ says the reviewer assigned to your case is named in the acknowledgement letter, and status questions go to that reviewer.

6. 06

   Watch the alert

   When FDA removes the firm or product, the removal is published on the import alert. FDA's FAQ says publication generally serves as the notification.

Import Alert 99-41 lists importers that appear not to comply with the FSVP regulation, not foreign suppliers. Its Guidance section says the importer should send removal information to the FDA compliance officer or office that issued the regulatory letter notifying it of the FSVP violations, that submissions must be in English, and that FDA may conduct a follow-up FSVP inspection.

The alert also says the foreign supplier is not responsible for demonstrating that the importer's violations are resolved, and that FDA offices should direct foreign suppliers who ask to contact the relevant importer.

FDA's FAQ covers two cases. If a firm believes it was incorrectly declared as the manufacturer, shipper or importer, it may file a Freedom of Information Act request to see how it was identified, and petition for removal with the evidence. If a firm no longer makes the listed product, it may petition, but FDA says a petition is not appropriate for products only temporarily out of production.

Under FSVP, a supplier's listing is new information that calls for a prompt reevaluation under 21 CFR 1.505(c)(1). FDA's 2023 FSVP guidance (Question E.9) says you should determine whether you need to obtain the food from a different supplier, permanently or until the reevaluation is complete. Question H.5 adds that the supplier's actions to get off the alert might be appropriate corrective actions for your FSVP if they correct the underlying problem.