Import Alert 12-13
(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 12-13
Published Date: 05/22/2026
Type: DWPE
Import Alert Name:
Detention Without Physical Examination of Milk and Milk Products Manufactured under Insanitary Conditions
Reason for Alert:
Note: The revision of this Import Alert (IA) dated 05/22/2026 updates the guidance section including agency contacts and PAC. Changes to the import alert are bracketed by asterisks (***).
FDA conducts inspections of foreign processors of milk and milk products to ensure products being offered for import into the US are safe and are manufactured under sanitary conditions in conformance with the FD&C Act and under Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation, Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). For example, measures such as pasteurizing (or other alternatives to pasteurizing such as aging) that are taken to destroy or prevent the growth of undesirable microorganisms, particularly those of public health significance, shall be adequate under the conditions of manufacture, holding, and distribution to prevent food from being adulterated (21 CFR 117.80(c)(4)). FDA assesses processors' pasteurization systems, including whether they are being adequately implemented, whether milk and milk products are being aged appropriately, and if other insanitary conditions exist which may reasonably cause contamination of product.
FDA may pursue regulatory action(s) based on inspectional observations or other evidence (e.g., noncompliance with Current Good Manufacturing Practice or Preventive Control requirements) gathered during foreign inspections of milk and milk products manufacturers that demonstrate improper pasteurization, inadequate aging, or other insanitary conditions which may result in the contamination of milk and milk products.
FDA conducts inspections of foreign processors of milk and milk products to ensure products being offered for import into the US are safe and are manufactured under sanitary conditions in conformance with the FD&C Act and under Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation, Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). For example, measures such as pasteurizing (or other alternatives to pasteurizing such as aging) that are taken to destroy or prevent the growth of undesirable microorganisms, particularly those of public health significance, shall be adequate under the conditions of manufacture, holding, and distribution to prevent food from being adulterated (21 CFR 117.80(c)(4)). FDA assesses processors' pasteurization systems, including whether they are being adequately implemented, whether milk and milk products are being aged appropriately, and if other insanitary conditions exist which may reasonably cause contamination of product.
FDA may pursue regulatory action(s) based on inspectional observations or other evidence (e.g., noncompliance with Current Good Manufacturing Practice or Preventive Control requirements) gathered during foreign inspections of milk and milk products manufacturers that demonstrate improper pasteurization, inadequate aging, or other insanitary conditions which may result in the contamination of milk and milk products.
Guidance:
Divisions may detain without physical examination milk and milk products from the foreign processors (manufacturers) identified on the Red List of this import alert.
***This IA does not apply to violations of the Act based on analytical evidence. Additionally, low-acid, acidified or aseptic milk and milk products are not subject to this alert.
The evidence supporting recommendations for addition to the Red List of this IA will be evaluated by the Human Foods Program (HFP). Such evidence may include inspectional findings demonstrating:
- Manufacturing of unpasteurized or inadequately pasteurized product (e.g., deficiencies in pasteurization systems or in monitoring of critical production/processing parameters such as time or temperature, that may affect other critical factors);
- Inadequate aging;
- Other insanitary conditions (e.g., deficiencies in sanitation practices or inadequate controls to protect food from physical, chemical or microbiological contamination).
Based on the totality of the evidence, HFP may recommend detention without physical examination (DWPE) for the foreign processor/product(s) combination, and addition to the Red List of this IA. Final recommendations for additions to the Red List of this IA, should be forwarded to the Division of Import Operations (DIO).***
Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):
*** To remove a firm’s product from the Red List, the firm must provide information that adequately demonstrates it has resolved the conditions that gave rise to the appearance of a violation. This information is necessary for the Agency to have confidence that future shipments or entries will be in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
This may include documentation (in English) including records to show corrections implemented since the FDA inspection. The documentation may include reports from a foreign competent authority or third-party inspection of the manufacturing facility demonstrating that the milk or milk product was manufactured in accordance with CGMPs.
For additional guidance on removal from detention without physical examination, refer to FDA’s Regulatory Procedures Manual (RPM), Chapter 9-8, “Detention Without Physical Examination (DWPE).”***
*** If a firm and/or a representative thereof would like to petition for removal from DWPE under this IA, all relevant information supporting the request should be sent via email to: Importalerts2@fda.hhs.gov
Questions or issues involving import operations or the submissions of petitions for removal from DWPE should be addressed to OII/OIO/DIO (301) 796-0356 or Imports@fda.hhs.gov
Questions or issues with regard to human food on policy or any additional questions not directly related to a detained entry, should be addressed to HFP/Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov
***
***This IA does not apply to violations of the Act based on analytical evidence. Additionally, low-acid, acidified or aseptic milk and milk products are not subject to this alert.
The evidence supporting recommendations for addition to the Red List of this IA will be evaluated by the Human Foods Program (HFP). Such evidence may include inspectional findings demonstrating:
- Manufacturing of unpasteurized or inadequately pasteurized product (e.g., deficiencies in pasteurization systems or in monitoring of critical production/processing parameters such as time or temperature, that may affect other critical factors);
- Inadequate aging;
- Other insanitary conditions (e.g., deficiencies in sanitation practices or inadequate controls to protect food from physical, chemical or microbiological contamination).
Based on the totality of the evidence, HFP may recommend detention without physical examination (DWPE) for the foreign processor/product(s) combination, and addition to the Red List of this IA. Final recommendations for additions to the Red List of this IA, should be forwarded to the Division of Import Operations (DIO).***
Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):
*** To remove a firm’s product from the Red List, the firm must provide information that adequately demonstrates it has resolved the conditions that gave rise to the appearance of a violation. This information is necessary for the Agency to have confidence that future shipments or entries will be in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
This may include documentation (in English) including records to show corrections implemented since the FDA inspection. The documentation may include reports from a foreign competent authority or third-party inspection of the manufacturing facility demonstrating that the milk or milk product was manufactured in accordance with CGMPs.
For additional guidance on removal from detention without physical examination, refer to FDA’s Regulatory Procedures Manual (RPM), Chapter 9-8, “Detention Without Physical Examination (DWPE).”***
*** If a firm and/or a representative thereof would like to petition for removal from DWPE under this IA, all relevant information supporting the request should be sent via email to: Importalerts2@fda.hhs.gov
Questions or issues involving import operations or the submissions of petitions for removal from DWPE should be addressed to OII/OIO/DIO (301) 796-0356 or Imports@fda.hhs.gov
Questions or issues with regard to human food on policy or any additional questions not directly related to a detained entry, should be addressed to HFP/Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov
***
Product Description:
Milk and Milk Products: milk, cream, cheese, and all other milk-based products.
See Guidance for exclusions.
See Guidance for exclusions.
Charge:
For Inadequate Pasteurization, Inadequate Aging, or Other Insanitary Conditions:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary
conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health." [Adulteration, Section
402(a)(4)]
OASIS charge code: INSANITARY
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary
conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health." [Adulteration, Section
402(a)(4)]
OASIS charge code: INSANITARY
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
GERMANY
Edelweiss Gmbh & Co., KG
Date Published : 09/18/2013
Oberstdorfer Str. 7
, Kempten (Allgau),
Bavaria GERMANY
12 A - - 56 Soft Ripened Cheese Made from Cow's Milk (e.g., brie, camembert)
Date Published: 09/18/2013
Desc: Blue Brie Cheese
Notes: Inadequate Pasteurization