For guidance on removal from DWPE, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE). The purpose of this is so the agency will have confidence that future shipments will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). Following receipt and review of private laboratory analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.*** Removal from Detention without Physical Examination (REMOVE FROM RED LIST): ***In order to remove a firm's product from the Red List, information should be provided to the agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. For further information regarding private laboratory analyses, please reference FDA's ORA Lab Manual, volume III, section 7. Evidence should be submitted to the appropriate FDA Division compliance office for consideration per the notice of detention. Such evidence could include private laboratory analysis of a representative sample of the detained product. Firms found to have recurring Salmonella violations under this alert may be subjected to further regulatory enforcement due to the appearance of a lack of or inadequate preventive controls or inadequate GMPs, under Import Alert #99-43, "Detention Without Physical Examination Of Ready-To-Eat Human Food Products That Appear To Have Been Prepared, Packed, Or Held Under Insanitary Conditions."*** Release of Articles Subject to Detention Without Physical Examination Under This Import Alert: In order to secure release of an individual shipment subject to DWPE under this import alert, the owner, consignee, and/or other responsible party for the affected goods should provide ***evidence which demonstrates that the product does not bear or contain Salmonella. ***Divisions may detain without physical examination (DWPE), shipments of the products from firms identified on the Red List of this Alert. Commodities not covered by this alert: Seafood and seafood products are covered by other import alerts under Industry Code 16 coconut and coconut products are covered by Import Alert #23-12 cheese and cheese products are covered by Import Alert #12-10 papaya from Mexico is covered by Import Alert #21-17 cantaloupe from Mexico is covered by Import Alert #22-01 black pepper from India and Brazil is covered by Import Alerts #28-02 and #28-04 respectively).*** Guidance: This alert applies to products that appear to be adulterated due to the presence of Salmonella, that are not covered by other import alerts. It can be found in many different foods including spices, meats, seafood, and produce. Centers for Disease Control and Prevention estimates that Salmonella bacteria cause about 1.35 million infections, 26,500 hospitalizations, and 420 deaths in the United States every year, with food being the source for most of these illnesses. ***Salmonella is the name of a group of pathogenic bacterium which is a leading cause of foodborne illness in the United States. Changes to the import alert are bracketed by asterisks (***). Note: The revision of this Import Alert (IA) dated updates the reason for alert, guidance section, agency contacts and product description.
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