NOTE: The revision to this import alert dated July 15, 2025, updates the name of alert, reason for alert, guidance section, program and center contacts and PAC code. Changes are noted and bracketed by three asterisks (***). ***As part of FDA's activities intended to protect the health and safety of US consumers, FDA performs foreign inspections and remote regulatory assessments of pharmaceutical establishments engaged in the manufacture, processing, packing, or holding of drugs or drug products intended for sale in the US. Detention without physical examination may be appropriate when information has revealed that a firm is not operating in conformity with current good manufacturing practice requirements (CGMP). In part, the Federal Food, Drug, and Cosmetic Act (FD&C Act) Section 201(g)(1) defines "drug" as �(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause�(B), or (C).�***
Various drugs (See attachment)
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B)." OASIS Charge Code: DRUG GMPS
***Divisions may detain, without physical examination, the indicated drugs or drug products from the foreign establishments on the Red List of this Import Alert. Divisions should follow the guidance in the Regulatory Procedures Manual (RPM) Chapter 9-2 for Personal Importation shipments. Commercial or promotional shipments, and products subject to DWPE are generally not amenable to the use of enforcement discretion, including Personal Importation. Note that personal importation is not allowed for unapproved animal drugs. Detention without physical examination may be appropriate when an FDA inspection, remote regulatory assessment, or inspection conducted by foreign or other government authorities under a Memorandum of Understanding or other agreement reveals that an establishment is not operating in conformity with CGMPs. FDA's Center for Drug Evaluation and Research (CDER) or Center for Veterinary Medicine (CVM), as applicable, will evaluate regulatory inspections or remote regulatory assessments on a case-by-case basis. Release of Articles Subject to Detention without Physical Examination under This Import Alert: In order to secure release of an entry detained pursuant to this Import Alert, the owner, consignee, and/or other responsible party for the affected goods should provide documentation to the FDA Division compliance office to demonstrate that the CGMP violation(s) for the affected product(s) have been adequately corrected. CDER (for human drugs) or CVM (for animal drugs) will review the firm's documentation to determine whether the entry may be released. Removal from Detention without Physical Examination (REMOVE FROM RED LIST): In order to remove a foreign establishment's product from the Red List of this Import Alert, information should be provided to the Agency to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation. This may include a letter detailing the corrective actions, accompanied by documentation. For guidance on removal from detention without physical examination, refer to FDA�s Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination (DWPE)". DWPE of such firms may apply until FDA has confidence that future shipments will not appear violative. For example, FDA may determine this by inspection of the facility. When the listing of a foreign establishment on the Red List of this Import Alert is coupled with other Agency compliance actions, such as warning letters, regulatory meetings, and response letters, etc., FDA will generally conduct an inspection to confirm that corrective actions have been implemented prior to closing the matter and removing the firm from the Red List of this import alert. Requests for removal from this Import Alert should be submitted to the CDER Office of Compliance Office of Manufacturing Quality at CDER-OC-OMQ-Communications@fda.hhs.gov (for human drugs).*** ***Questions or issues involving import operations should be addressed to the ORA/Division of Import Operations (DIO) at 301-796-0356 or FDAImportsInquiry@fda.hhs.gov. Questions or issues on policy, or any other additional questions regarding animal drug products, should be addressed to the Center for Veterinary Medicine (CVM), Compliance Support Branch (HFV- 215)at CVMImportRequests@fda.hhs.gov Questions or issues involving compliance of imported human drug products should be addressed to the CDER Imports Compliance Branch at CDERImports@fda.hhs.gov. ***
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: NOTE: The revision to this import alert dated July 15, 2025, updates the name of alert, reason for alert, guidance section, program and center contacts and PAC code. Changes are noted and bracketed by three asterisks (***). ***As part of FDA's activities intended to protect the health and safety of US consumers, FDA performs foreign inspections and remote regulatory assessments of pharmaceutical establishments engaged in the manufacture, processing, packing, or holding of drugs or drug products intended for sale in the US. Detention without physical examination may be appropriate when information has revealed that a firm is not operating in conformity with current good manufacturing practice requirements (CGMP). In part, the Federal Food, Drug, and Cosmetic Act (FD&C Act) Section 201(g)(1) defines "drug" as �(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause�(B), or (C).�***
Country-specific information is available in the full alert detail on the FDA website.
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