Rely on SCS Global Services to respond to your crisis management needs related to FDA detention. SCS consultants guide you through the FDA import detention clearance process with expert consulting, expedited agricultural residue sampling, and testing services. In addition, SCS provides solutions for importers placed on the FDA Import Alert list, and for products being held for detention without examination (i.e., automatic detention).
For companies faced with an FDA import detention, swift action is essential. The FDA Notice of Action form sets a deadline for your response. SCS serves as your liaison with the FDA to expedite this process:
The FDA detention process applies to products that have been detained for pesticides, filth, heavy metals, non-approved food colorants, and food additives.
After an exporter is placed on FDA detention, every new shipment must then be analyzed by an independent laboratory for the same illegal residue. Shipments found to contain residues below the established Levels of Quantification (LOQ) are cleared for release. After five clean shipments, the exporter may petition to be removed from the Import Alert list. SCS provides the testing services you need, and will help you prepare your petition for clearance.
Under the recently enacted Food Safety Modernization Act’s (FSMA) Foreign Supplier Verification ruling, importers of record are now responsible for ensuring that their food suppliers meet US EPA pesticide residue tolerances and FDA food safety requirements. As a result, the FDA has increased surveillance of imported foods, and the process for gaining clearance from FDA detention is now more costly and time consuming than ever before.
In addition to providing evidence of FDA compliance for five consecutive shipments, importers must now provide a Corrective and Preventive Action (CAPA) letter, which defines prevention and control measures for addressing the initial cause for detention, and includes a root cause analysis.