NOTE: The revision of this Import Alert, dated 12/10/2024, updates the reason for alert section, Agency contacts, and includes additional guidance on exemptions covered under detention without physical examination. Changes are bracketed by asterisks (***). REASON FOR ALERT: As part of FDA's activities intended to protect the health and safety of US consumers, FDA often conducts establishment inspections ***and remote regulatory assessments*** of foreign drug manufacturers who produce FDA-regulated articles intended for sale in the US. As part of FDA's foreign inspection process, the Agency may contact the foreign drug manufacturer and schedule the establishment inspection; however, there is no such requirement to do so. ***Additionally FDA may conduct a mandatory remote regulatory assessment, such as a 704(a)(4) Records Request.*** Access to these facilities is a critical aspect of protecting the health and safety of US citizens from unsafe products of foreign origin. The Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law on July 9, 2012. Section 707 of FDASIA added a new section 501(j) to the Federal Food, Drug, and Cosmetic Act (FD&C Act), making a drug adulterated if it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection. Articles of drug that have been manufactured, processed, packed, or held in any factory, warehouse, or establishment of which the owner, operator, or agent has delayed, denied, or limited an inspection, or refused to permit entry or inspection, appear to be adulterated and are subject to refusal of admission under section 801(a)(3) of the FD&C Act.
Various Drugs (refer to Red List)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to be adulterated under Section 501(j) because it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection. [Adulteration, Section 501(j)] OASIS Charge Code � DRG REF EI
Divisions may detain without physical examination shipments of drugs from firms listed on the Red List of this Import Alert under Section 801(a)(3) as being adulterated under Section 501(j). Generally, drugs imported from the firm(s) listed on the Red List to this Import Alert should remain subject to detention without physical examination until an FDA inspection is completed. In order to secure release of an entry subject to detention without physical examination under this Import Alert, the importer and/or another responsible party to the entry should provide evidence to the FDA Division compliance officer to demonstrate that the entry does not contain drugs that appear to be adulterated. CDER/OC/ODSIR/DGDDP/ICB will evaluate on a case-by-case basis. ***Divisions should follow the guidance in the Regulatory Procedures Manual (RPM) for Personal Importation shipments. Commercial or promotional shipments of products subject to DWPE are generally not amenable to the use of enforcement discretion, including Personal Importation.*** Removal from Detention without Physical Examination (REMOVE FROM RED LIST): 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 condition (refusal of FDA inspection ***or refusal to respond to a mandatory remote regulatory assessment***) that gave rise to the appearance of the violation so the agency will have confidence that future entries will be in compliance with the FD&C Act. For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention without Physical Examination (DWPE)". ***If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, submit a request (which may include copies of inspection reports for inspections performed by third parties only to assist FDA in prioritizing inspection requests) to Importalerts2@fda.hhs.gov.*** Requests for removal from detention without physical examination will be referred to CDER/OC/ODSIR/DGDDP/ICB for evaluation. Questions or issues involving import operations or the submission of petitions for removal from DWPE should be addressed to OII/DIO (301) 796-0356 or Imports@fda.hhs.gov *** *** Questions or issues involving import policy of drugs subject to this Import Alert should be addressed to CDER/OC/ODSIR/DGDDP/ICB at CDERImports@fda.hhs.gov.
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: NOTE: The revision of this Import Alert, dated 12/10/2024, updates the reason for alert section, Agency contacts, and includes additional guidance on exemptions covered under detention without physical examination. Changes are bracketed by asterisks (***). REASON FOR ALERT: As part of FDA's activities intended to protect the health and safety of US consumers, FDA often conducts establishment inspections ***and remote regulatory assessments*** of foreign drug manufacturers who produce FDA-regulated articles intended for sale in the US. As part of FDA's foreign inspection process, the Agency may contact the foreign drug manufacturer and schedule the establishment inspection; however, there is no such requirement to do so. ***Additionally FDA may conduct a mandatory remote regulatory assessment, such as a 704(a)(4) Records Request.*** Access to these facilities is a critical aspect of protecting the health and safety of US citizens from unsafe products of foreign origin. The Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law on July 9, 2012. Section 707 of FDASIA added a new section 501(j) to the Federal Food, Drug, and Cosmetic Act (FD&C Act), making a drug adulterated if it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection. Articles of drug that have been manufactured, processed, packed, or held in any factory, warehouse, or establishment of which the owner, operator, or agent has delayed, denied, or limited an inspection, or refused to permit entry or inspection, appear to be adulterated and are subject to refusal of admission under section 801(a)(3) of the FD&C Act.
Country-specific information is available in the full alert detail on the FDA website.
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