Note: The revision of this Import Alert (IA) dated 10/15/2021 updates the name of the alert, reason for alert, guidance section, and charge section. Changes to the import alert are bracketed by asterisks (***). ***FDA collects and analyzes samples of finished dosage form drug products, active pharmaceutical ingredients (APIs), and inactive ingredients considered at risk for potentially hazardous microbial contamination that pose a health risk. Detention without physical examination may be appropriate when sample results reveal a potential health risk. ***
CDER regulated finished dosage form drug products, active pharmaceutical ingredients, and inactive ingredients
*** The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that the article contains potentially hazardous, or otherwise objectionable in light of intended use, microbial adulteration and therefore consists in part of a filthy substance. [Adulteration, Section 501(a)(1)] OASIS CHARGE CODE: FILTH AND/OR The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions [Insanitary Manufacturing, Processing or Packing, Section 801(a)(1)] OASIS CHARGE CODE: MFR INSAN AND/OR The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health [Adulteration, Section 501(a)(2)(A)] OASIS CHARGE CODE: INSANITARY AND/OR 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) [Adulteration, Section 501(a)(2)(B)] OASIS CHARGE CODE: DRUG GMPs ***
Divisions may detain, without physical examination, shipments of the products identified on the Red List of this Alert. If the article appears to be adulterated due to nonadherence to current good manufacturing practice (CGMP) requirements (DRUG GMPS) and is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA considers reconditioning or submission of analytical results to be insufficient to overcome the appearance of the violation. Recommendation for addition to DWPE under this import alert when analytical results reveal the presence of potentially hazardous microbial contamination of finished dosage form drug products, APIs, or inactive ingredients intended for pharmaceutical use should be forwarded to the Division of Import Operations (DIO) for review. Recommendations should include background information, analytical worksheets, product labeling, and entry documents. DIO will coordinate the review of the DWPE recommendation with CDER/OC/ODSIR/DGDDP/ICB for concurrence. *** *** Removal from Detention without Physical Examination (REMOVE FROM RED LIST): Firms that would like to be removed from DWPE should provide information to FDA to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance. This may include a letter detailing the firm's corrective actions, accompanied by supporting documentation. All relevant information supporting the request should be forwarded to the following address: Food and Drug Administration Division of Import Operations 12420 Parklawn Drive, ELEM-3109 Rockville, MD 20857 Or, via email to: Importalerts2@fda.hhs.gov.*** ***Questions or issues involving import operations should be addressed to ORA/DIO at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov Questions or issues involving science, science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/ Office of Regulatory Science at FDAPRIVATELABIMPORTALERTS@fda.hhs.gov Questions or issues involving compliance of imported drug products, APIs, or inactive ingredients 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 (IA) dated 10/15/2021 updates the name of the alert, reason for alert, guidance section, and charge section. Changes to the import alert are bracketed by asterisks (***). ***FDA collects and analyzes samples of finished dosage form drug products, active pharmaceutical ingredients (APIs), and inactive ingredients considered at risk for potentially hazardous microbial contamination that pose a health risk. Detention without physical examination may be appropriate when sample results reveal a potential health risk. ***
Country-specific information is available in the full alert detail on the FDA website.
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