Import Alert 99-32: What Happens When You Refuse an FDA Inspection

When the FDA attempts to inspect a foreign food facility and the facility refuses, delays, or limits the inspection, the consequences are severe and immediate. The agency issues Import Alert 99-32, which authorizes Detention Without Physical Examination (DWPE) for all products from the affected facility. This means every shipment from your facility will be automatically detained at the US border — no sampling required, no laboratory analysis needed, no opportunity to demonstrate that the specific shipment is compliant. The detention is based on your refusal to allow inspection, and it remains in effect until you take specific corrective actions to the FDA's satisfaction.

Understanding Detention Without Physical Examination

DWPE is one of the FDA's most powerful enforcement tools for imported products. Under normal circumstances, the FDA selectively examines imported food shipments based on risk factors, compliance history, and random sampling. When a DWPE is in effect, that selective approach is replaced by a blanket detention order. Every line entry from the affected facility is flagged in the FDA's PREDICT system and detained automatically. The importer receives a detention notice and must either export the goods, destroy them, or submit evidence to overcome the detention — a process that is expensive, time-consuming, and rarely successful without addressing the root cause.

Types of Import Alerts

The FDA maintains dozens of active import alerts covering different products, hazards, and countries. Some apply to entire countries — for example, alerting inspectors to detain all seafood from a specific nation due to systemic veterinary drug residue problems. Others target specific manufacturers, shippers, or products. Import Alert 99-32 is unique because it is triggered not by a product safety issue but by the facility's refusal to permit an FDA inspection. The underlying logic is straightforward: if you will not let the FDA verify your food safety systems, the agency will assume those systems are inadequate and detain your products accordingly.

Country-Wide vs. Facility-Specific Alerts

Country-wide import alerts create a presumption of non-compliance for all facilities in a given country producing a given type of product. Facility-specific alerts — including 99-32 — target individual establishments. Being placed on a facility-specific alert is particularly damaging because it signals to the FDA that your specific operation has a compliance failure. It also means that getting removed from the alert requires facility-specific corrective action, not just general improvements in your country's food safety infrastructure.

The FDA Red List

Facilities subject to an import alert are placed on the FDA's 'Red List' — a publicly searchable database of firms whose products are subject to DWPE. The Red List includes the facility name, address, country, product codes, and the specific import alert number. US importers, retailers, and distributors routinely check the Red List before engaging new foreign suppliers. Appearing on the Red List is not just an import barrier — it is a reputational stain that is visible to your competitors, your customers, and your potential business partners.

The 24-Hour Response Window

When the FDA arrives at your foreign facility for an inspection, you have an extremely limited window to respond. The FDA expects facilities to be ready for inspection during normal business hours. While the agency typically provides advance notice for foreign inspections through the Foreign Inspection Program, the expectation is that your facility will be available and prepared. Delays in granting access, restricting inspector access to certain areas, failing to produce requested records, or refusing entry entirely can all be classified as inspection refusal. Once the FDA investigator files a report documenting the refusal, the import alert process moves quickly — often within days.

What Constitutes Refusal

Refusal is not limited to physically blocking an inspector at the door. The FDA considers the following actions as refusal: denying entry to any part of the facility, failing to provide records requested during the inspection, providing incomplete or misleading information, delaying the inspection to the point where the investigator cannot complete their work, and having the facility closed or inaccessible when the FDA arrives at a pre-arranged time. Even well-intentioned delays — such as asking the inspector to return while you contact your attorney — can be documented as obstruction.

How to Get Removed from the Red List

Getting removed from Import Alert 99-32 requires demonstrating to the FDA that you have addressed the reasons for the refusal and that your facility is now willing and able to undergo inspection. The typical process involves submitting a written commitment to permit full FDA inspection access, providing comprehensive documentation of your food safety systems (including food safety plans, HACCP plans, monitoring records, and corrective actions), arranging for a successful FDA inspection or providing evidence from a qualified third-party audit, and demonstrating sustained compliance over a review period. The process can take months to years, depending on the severity of the initial refusal and the quality of your corrective actions.

Mock Inspections: Your Best Preparation

The most effective way to prevent Import Alert 99-32 — and to prepare for any FDA inspection — is to conduct regular mock inspections. A mock inspection simulates the FDA inspection process, evaluating your facility against the same criteria an FDA investigator would use. This includes reviewing your food safety plan, walking the production floor, examining cleaning and sanitation procedures, verifying monitoring records, testing employee knowledge of food safety protocols, and assessing your recall readiness. Mock inspections identify gaps before the FDA does, giving you time to implement corrective actions without regulatory consequences.

What a Mock Inspection Covers

A thorough mock inspection evaluates facility design and maintenance, employee hygiene practices, raw material receiving and storage, process controls and critical control points, allergen management, pest control programs, water safety, chemical storage, labeling accuracy, traceability systems, and record-keeping practices. The mock inspection report should identify findings using the same classification system the FDA uses — critical, major, and minor observations — so that you can prioritize corrective actions appropriately.

FDABridge helps foreign food manufacturers prepare for FDA inspections through mock inspection programs, food safety plan development, and import alert resolution services. If your facility is already on the Red List, our team can guide you through the corrective action and removal process. Visit fdabridge.com/food to learn about our inspection readiness services, or contact us at fdabridge.com/contact to discuss your situation confidentially.