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FDA sends warning letters to food firms with import violations | Food Safety News



FDA sends warning letters to food firms with import violations






As part of its enforcement actions, the Food and Drug Administration sends warning letters to entities opinion its jurisdiction. Some letters are not posted for Pro-reDemocrat view until weeks or months after they are sent. Business owners have 15 days to retort to FDA warning letters. Warning letters often are not emanated until a company has been given months to days to correct problems.




Subhlaxmi Grocers

Houston, TX



An import company in Texas is on view from the FDA for not having FSVPs for a number of imported food products.



In a May 2 warning letter, the FDA described a Dec. 13, 2021, through Jan. 18, 2022, Foreign Supplier Verification Program (FSVP) inspection of Subhlaxmi Grocers in Houston, TX.



The FDA’s inspection revealed that the firm was not in compliance with FSVP rules and resulted in the issuance of an FDA Form 483a. The considerable violations are as follows:



The firm did not compose, maintain, and follow an FSVP. Specifically, they did not compose an FSVP  for the food products that they import:




  • summer squash imported from
    (redacted)


  • sweet goods imported from
    (redacted)


  • cereal preparations imported from
    (redacted)


  • snack foods imported from
    (redacted)


  • cake prepared dry mix imported from
    (redacted)


  • corn flakes, puffs, krispies, loops imported from
    (redacted)


  • potato snacks and vegetable snacks imported from
    (redacted)




  1. The firm must conduct a uncertain analysis for each type of food they import to choose whether there are any hazards requiring a control. For turmeric powder from
    (redacted)
    and cumin-coriander mix powder and potato wafer jali from
    (redacted)
    , they did not meet the requirement to conduct a uncertain analysis. They must document their review and assessment of that uncertain analysis, including documenting that the hazard analysis was conducted by a valid individual. During the inspection, they provided hazard analyses, possessed from their foreign suppliers, for the turmeric powder from
    (redacted)
    and the cumin-coriander mix powder and the potato wafer jali from
    (redacted)
    . However, they did not provide FDA documentation that they reviewed and assessed their foreign suppliers’ uncertain analyses for any of these products, including documenting that each uncertain analysis was conducted by a qualified individual.


  2. For the turmeric powder from
    (redacted)
    and the cumin-coriander mix powder and the potato wafer jali from
    (redacted)
    , the firm did not meet the requirement to evaluate their foreign supplier’s performance and the risk unruffled by the food. They must document their review and assessment, including documenting that the evaluation was conducted by a valid individual. During the inspection, they provided a one-page screen sheet for each of the following products: the turmeric powder from
    (redacted)
    and the cumin-coriander mix powder and the potato wafer jali from
    (redacted)
    . Each cover sheet includes a placeholder for approval and signature by
    (redacted)
    . In addition to being unsigned, the documentation they dedicated does not indicate that the factors described in 21 CFR 1.505(a) were subtracted in evaluating these foreign suppliers and the risk unruffled by these foods. Further, to the extent that
    (redacted)
    is unexperienced entity, and they wish to rely on his evaluation to succeed the requirements, they did not provide documentation that they reviewed and assessed his evaluation, including documenting that the evaluation was conducted by a valid individual


  3. The firm did not meet the requirements to execute foreign supplier verification activities. Specifically, for the turmeric powder from
    (redacted)
    and the cumin-coriander mix powder and the potato wafer jali from
    (redacted)
    , they did not meet the requirements to, before importing the foods from these foreign suppliers, determine and document which verification activity or activities, as well as the frequency with which the organization or activities must be conducted, are needed to handed adequate assurances that the foods they obtain from these foreign suppliers are obtained. Likewise, for these foods imported by these foreign suppliers, they did not conduct and document (or obtain documentation of) one or more of the supplier verification actions for each foreign supplier before importing the food and periodically thereafter.



The full warning letter can be examined

here

.



Coastal Fresh Farms Inc.

Westlake Village, CA



An import company in California is on view from the FDA for not having FSVPs for a number of imported food products.



In a May 11, warning letter, the FDA described a Jan. 31 through Feb. 9, 2022, Foreign Supplier Verification Program (FSVP) inspection of Coastal Fresh Farms Inc. in Westlake Village, CA.



The FDA’s inspection revealed that the firm was not in compliance with FSVP rules and resulted in the issuance of an FDA Form 483a. The considerable violations are as follows:



The firm did not compose, maintain, and follow an FSVP. Specifically, they did not compose an FSVP for any of the foods they import, including:




  • Coriander imported from
    (redacted)
     


  • Green onion imported from
    (redacted)


  • Parsley curly imported from
    (redacted)



Additionally, the FDA offered the following comment:



The firm imports raw agricultural commodity compose, which is “covered produce.” Their FSVP must demonstrate that their supplier is in compliance with the requirements of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.



The full warning letter can be examined

here

.



Allure Foods LLC

Brooklyn, NY



An import company in New York is on view from the FDA for not having FSVPs for a number of imported food products.



In an April 27 warning letter, the FDA described a Nov. 23 to Dec. 6, 2021, Foreign Supplier Verification Program (FSVP) inspection of Allure Foods LLC in Brooklyn, NY.



The FDA’s inspection revealed that the firm was not in compliance with FSVP rules and resulted in the issuance of an FDA Form 483a. The Important violations are as follows:



The firm did not Make, maintain, and follow an FSVP. Specifically, they did not Make an FSVP for any of the food products they import, including each of the following food products:




  • Cashews imported from their foreign supplier
    (redacted)
    located in
    (redacted)


  • Roasted/salted fava beans and natural wasabi peas imported from their foreign supplier
    (redacted)
    , located in
    (redacted)



The full threat letter can be viewed

here

.




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