Import Alert 99-32: What Happens If I Refuse FDA Inspection?
FDA inspections of food establishments, both domestic and foreign, are vital for identifying food safety issues. Under section 704 of the FD&C Act, FDA representatives are authorized to conduct inspections, including those of foreign establishments whose products are imported into the U.S. The FDA Food Safety Modernization Act (FSMA) expanded FDA’s authority to ensure imported food meets U.S. standards.
Scheduling Foreign Food Establishment Inspections
While the FD&C Act doesn’t mandate pre-announced inspections, the FDA typically contacts foreign firms beforehand to facilitate the process. Coordination with foreign governments is essential, involving written inspection requests and confirmation of inspection dates. Foreign government representatives may accompany FDA investigators during inspections.
Establishment Inspection Activities
During inspections, FDA investigators observe food-related operations, review records, and may collect samples for analysis. They also take photographs to document conditions. Cooperation from establishment personnel is crucial, including timely provision of requested records.
- Understanding Import Alerts and FDA Inspections
Refusal encompasses actions or behaviors that prevent or delay scheduling or conducting inspections. This includes situations where an establishment or foreign government obstructs entry or interferes with inspection activities, such as denying access to certain areas or records.
When facilities outside the U.S. decline FDA inspections, they risk being placed on Import Alert 99-32, leading to Detention Without Physical Examination (DWPE) of their products. This alert enables the FDA to seize items and categorizes the establishment on an FDA Red List until a successful inspection is completed.
FDA Enforcement of Section 807(b)
FDA’s Import Alert 99-32 lists foreign food establishments that refuse inspections. Food from establishments on the Red List may be refused admission into the U.S. FDA provides avenues for contesting refusal determinations and requesting inspection rescheduling. Refusal by foreign governments may result in the inclusion of establishments on the Red List.
- Implications of Import Alerts
Import Alerts indicate a pattern of non-compliance, resulting in delayed or refused shipments, damaged relationships, and reputational harm. Establishments are strongly advised to cooperate with FDA inspections to ensure compliance with regulations.
- Purpose and Types of Import Alerts
Import Alerts aim to prevent non-compliant products from entering the U.S. and ensure uniform enforcement nationwide. They can be categorized based on country or area, worldwide issues, problematic shippers, or manufacturer and product-specific concerns.
- FDA Inspections and Compliance
FDA inspections of foreign food facilities are crucial for upholding U.S. standards. Facilities must respond promptly to inspection requests and prepare by adhering to FDA Current Good Manufacturing Practices (cGMPs) and other regulatory requirements.
- Addressing Import Alert 99-32
To be removed from Import Alert 99-32 and the FDA Red List, facilities must petition for an FDA inspection. Full cooperation is essential to expedite the process and prevent revenue loss. Providing evidence of corrective actions and compliance is necessary for removal.
- Assistance from Cosmereg
Cosmereg offers expertise in FDA compliance, assisting companies worldwide in navigating regulatory complexities. Services like mock FDA inspections can help identify and address potential issues, facilitating the removal of products from Import Alerts.
Final Guidance on Refusal of Inspection by a Foreign Food Establishment
Background
The FDA’s Final Guidance for Industry on the Refusal of Inspection by a Foreign Food Establishment elaborates on Section 807(b) of the FDA Food Safety Modernization Act (FSMA), which mandates refusal of food admission into the US if a foreign establishment refuses inspection by FDA officials.
Refusal of Inspection
The guidance interprets refusal broadly, encompassing actions, statements, or passive behaviors that obstruct scheduling or conducting inspections. Examples include delays in scheduling, preventing entry of FDA investigators, or hindering inspection processes.
Refusals by Foreign Governments
The guidance also outlines actions by foreign governments that FDA would consider as refusal, such as denying entry to FDA investigators or delaying inspection scheduling without valid reasons.
Consequences of Refusal
Refusal triggers placement on the Red List of Import Alert 99-22, potentially leading to refusal of admission for products from the establishment into the US. Establishments have the option to contest FDA’s decision or request an inspection to be removed from the Import Alert.
Changes from Draft Guidance
The Final Guidance omits the “good faith” exception and reinforces positions on actions constituting refusal. It emphasizes FDA’s authority to take photographs during inspections.
FDA Warning Letters After Remote Regulatory Assessment (RRA)
Background
FDA issued Warning Letters to foreign facilities following a Remote Regulatory Assessment (RRA) records review. RRAs are voluntary and aim to review regulated establishments and their records.
Warning Letters Issued
The Warning Letters addressed violations of FDA’s seafood Hazard Analysis and Critical Control Point (HACCP) regulation. Despite some companies responding to discussion items, the agency deemed their responses inadequate.
Implications
Information gathered during RRAs can support various actions, including regulatory meetings, warning letters, import actions, recalls, or enforcement actions.
Conclusion
These developments underscore FDA’s commitment to ensuring compliance with food safety regulations, both domestically and internationally. The agency’s enforcement actions emphasize the importance of adhering to regulatory requirements to safeguard public health.
If you have doubts about handling FDA Inspections or Warning letters Cosmereg can assist you in each step. For more information just contact us.
