Import Alert 12-13
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(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: 07/24/2012
Type: DWPE
Import Alert Name:
Detention Without Physical Examination of Dairy Products Manufactured under
Insanitary Conditions
Insanitary Conditions
Reason for Alert:
FDA conducts inspections of foreign processors of dairy 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 Practices (CGMP) found in the Manufacturing, Packing or Holding Human Food regulation (21 CFR 110). 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 110.80(b)(4)). FDA assesses processors¿ pasteurization systems, including whether they are being adequately implemented, whether dairy 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 gathered during foreign inspections of dairy manufacturers that demonstrate improper pasteurization, inadequate aging, or other insanitary conditions which may result in the contamination of dairy products.
FDA may pursue regulatory action(s) based on inspectional observations or other evidence gathered during foreign inspections of dairy manufacturers that demonstrate improper pasteurization, inadequate aging, or other insanitary conditions which may result in the contamination of dairy products.
Guidance:
Districts may detain, without physical sampling and analysis, dairy products from the foreign processors (manufacturers) as noted in the Red List of this import alert.
This import alert does not cover violations of the Act based on sample results.
When CFSAN has determined that inspectional findings demonstrate the manufacture of unpasteurized or inadequately pasteurized product (e.g., problems with pasteurization systems, or deficiencies in production/processing that may affect monitoring of temperature of other critical factors), inadequate aging, or other insanitary conditions (e.g., problems with overall sanitation operations and inadequate controls for protection of food against physical, chemical and microbiological contamination), the Center may recommend detention without physical examination for the foreign processor/product(s) combination, and a revision to incorporate the foreign processor in the Red List of this import alert.
Foreign processors listed on the Red List of this import alert who would like to request removal from that list should provide information to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that agency will have confidence that future entries will be in compliance. This may include documentation (in English), including records, to show corrections implemented since the FDA inspection. The documentation may include reports from a third-party (e.g., a government inspection authority) demonstrating that an audit of the processor was conducted and that the dairy product was manufactured in accordance with CGMPs.
The above documentation should be submitted to CFSAN's Office of Compliance, Division of Enforcement, at the following address:
Food and Drug Administration
Food Adulteration Assessment Branch (HFS-607)
5100 Paint Branch Parkway
College Park, MD 20740
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301-796-5992.
This import alert does not cover violations of the Act based on sample results.
When CFSAN has determined that inspectional findings demonstrate the manufacture of unpasteurized or inadequately pasteurized product (e.g., problems with pasteurization systems, or deficiencies in production/processing that may affect monitoring of temperature of other critical factors), inadequate aging, or other insanitary conditions (e.g., problems with overall sanitation operations and inadequate controls for protection of food against physical, chemical and microbiological contamination), the Center may recommend detention without physical examination for the foreign processor/product(s) combination, and a revision to incorporate the foreign processor in the Red List of this import alert.
Foreign processors listed on the Red List of this import alert who would like to request removal from that list should provide information to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that agency will have confidence that future entries will be in compliance. This may include documentation (in English), including records, to show corrections implemented since the FDA inspection. The documentation may include reports from a third-party (e.g., a government inspection authority) demonstrating that an audit of the processor was conducted and that the dairy product was manufactured in accordance with CGMPs.
The above documentation should be submitted to CFSAN's Office of Compliance, Division of Enforcement, at the following address:
Food and Drug Administration
Food Adulteration Assessment Branch (HFS-607)
5100 Paint Branch Parkway
College Park, MD 20740
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301-796-5992.
Product Description:
Dairy Products: milk, cream, cheese, and all other milk-based products.
This excludes low-acid, acidified or aseptic dairy products.
PROBLEM: Inadequate Pasteurization, Inadequate Aging or Other Insanitary Conditions
This excludes low-acid, acidified or aseptic dairy products.
PROBLEM: Inadequate Pasteurization, Inadequate Aging or Other Insanitary Conditions
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)]."
"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)]."
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