An FDA Import Alert is an enforcement communication used by FDA to identify imported products, firms, shippers, importers, countries, or other circumstances that appear to involve violations of U.S. law. When the applicable criteria are met, entries may be subject to Detention Without Physical Examination (DWPE). The specific reason, affected products or firms, and removal guidance are stated in the applicable Import Alert.

DWPE means Detention Without Physical Examination. It allows FDA to detain an entry without first physically examining the shipment when the product or firm meets the criteria of an applicable Import Alert. The importer may still submit testimony or evidence to try to obtain release of an individual shipment.

Drug-related Import Alerts can involve issues such as current good manufacturing practice concerns, unapproved or misbranded drugs, analytical failures, refusal of FDA inspection, or registration and listing problems. The exact basis must be determined from the specific Import Alert and the firm's FDA history before a removal strategy is prepared.

FDA Registration Assistance reviews the applicable Import Alert and listing, identifies the underlying compliance issues, organizes corrective and preventive actions, helps assemble supporting evidence, prepares the removal request or petition, and assists with follow-up communications. FDA makes the final decision on whether a firm or product is removed from DWPE.

FDA evaluates the totality of the evidence. Depending on the Import Alert, a removal package may include an investigation into the cause of the problem, corrective actions, preventive measures, supporting records, third-party audit information, laboratory evidence, compliant commercial shipments, inspection-related evidence, or other documentation showing that the conditions leading to DWPE have been resolved and are unlikely to recur.

No. There is no universal five-shipment rule for every Import Alert. FDA states that the evidence required varies by the nature of the violation and the applicable Import Alert. Some alerts may identify five consecutive non-violative commercial shipments as evidence, while other alerts may require different or additional evidence. The Guidance section of the specific Import Alert controls the removal strategy.

There is no fixed FDA processing time for removal from DWPE. Timing depends on the reason for the alert, the strength and completeness of the corrective-action evidence, whether inspections or clean shipments are needed, the applicable FDA Center or compliance office, and FDA's review workload. Complex CGMP or inspection-related matters can take substantially longer than documentation-based cases.

In some cases, yes. Release of an individual detained entry and removal of a firm or product from DWPE are separate matters. FDA allows the importer or consignee to present testimony or evidence showing that a particular shipment does not have the violation identified in the Import Alert. The specific release instructions are found in the Guidance section of the applicable alert.

Current drug Import Alerts cover issues such as CGMP deficiencies, unapproved new drugs, analytical test failures, foreign establishments refusing FDA inspection, and firms without valid drug registration or listing. Import Alert numbers and guidance can change, so the current FDA Import Alert database should be reviewed for every case.

A foreign drug establishment that is required to register under FDA's drug establishment rules must designate a U.S. Agent as part of its establishment registration. That registration obligation is separate from the Import Alert removal process. The removal request itself must follow the contact and submission instructions in the applicable Import Alert.

FDA Registration Assistance provides custom pricing because each Import Alert case is different. Scope depends on the reason for DWPE, the number of affected products or facilities, the amount of corrective-action documentation, whether laboratory or shipment evidence is needed, and the level of FDA follow-up required. A case review is used to define the scope before work begins.

No. No consultant can guarantee FDA removal from an Import Alert. FDA alone decides whether the evidence is sufficient to remove a firm or product from DWPE. Our role is to prepare a complete, organized, evidence-based request that addresses the applicable Import Alert criteria as directly as possible.

A corrective action plan documents what caused the apparent violation, what was corrected, what preventive controls were implemented, and what objective evidence shows the problem should not recur. The plan should be tailored to the reason for DWPE and supported by records rather than general promises of future compliance.

Yes. When an Import Alert is connected to CGMP deficiencies, an inspection, a remote regulatory assessment, or refusal of inspection, inspection-readiness work may be an important part of the overall strategy. Support can include review of quality-system documentation, CAPA records, procedures, manufacturing controls, and evidence showing that cited conditions have been corrected.

FDA makes the final removal decision. Most removal petitions are submitted to FDA's Division of Import Operations at the address identified by FDA, but some Import Alerts direct firms to a specific compliance office. The Guidance section of the applicable Import Alert should always be checked before a request is submitted.

Send us the Import Alert number, firm and facility name, affected products, recent detention or Notice of FDA Action documents, and any corrective-action, inspection, laboratory, or shipment records you already have. We will review the case, identify the applicable removal criteria, and provide a custom scope and strategy.