The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act).
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 food producer has resolved the conditions that gave rise to the appearance of the violation. Following receipt and review of analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.*** For residues regulated as combined residues (including isomers) or residues including metabolites and degradates, FDA will consider whether the private laboratory analyses address all the residues, including isomers, metabolites or degradates, as listed in 40 CFR part 180 in the applicable regulation. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, volume III, section 7. Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration, per the notice of detention. Such evidence may include private laboratory analysis of samples.
All requests for addition to DWPE will be evaluated by the Division of Import Operations (DIO) and when necessary will consult with the Center for Food Safety and Applied Nutrition (CFSAN), Office of Compliance, Division of Enforcement.*** Release of Articles Subject to Detention Without Physical Examination under This Import Alert: ***In order to secure release of an individual shipment identified for DWPE under this import alert, the owner, consignee and/or another responsible party to the shipment should provide evidence which demonstrates that the product does not bear or contain pesticide chemical residues that are unsafe within the meaning of section 408(a) of the Federal Food, Drug & Cosmetic Act (21 U.S.C. In accordance with Chapter 9 of the Regulatory Procedures Manual, recommendations for addition to detention without physical examination for raw agricultural commodity product(s) from an individual firm may be made after one violative entry if it contains actionable levels of a pesticide chemical residue and all other appropriate criteria are satisfied.
*** Divisions may detain, without physical examination, shipments of specified products from firms identified on the Red List of this Import Alert.
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