FDA Sent These 7 Warning Letters for Food Companies | September 2018

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FDA Sent These 7 Warning Letters for Food Companies | September 2018

By | 2018-11-01T21:58:19+00:00 November 1st, 2018|CGMP, FDA Enforcement News, FDA Inspections, FDA Warning Letters, Food, FSMA|

We took a snapshot of the 7 warning letters the FDA sent to food companies last month. Food violations ranged from failing to exclude rodents from site to failing to have an HACCP plan.

From companies in New York to Thailand, here they are:

  • Elwood International, Inc., Copiague, NY – violations include:
    • Failed to exclude pests from food plant to protect against contamination of food, as required by 21 CFR 117.35(c).
    • Failed to have plant constructed in such a manner that drip or condensate from fixtures, ducts, and pipes does not contaminate food, food-contact surfaces, or food packaging materials, as required by 21 CFR 117.20(b)(4).
    • Failed to take effective measures to protect against the inclusion of metal or other extraneous material in food, as required by 21 CFR 117.80(c)(8).
    • Failed to maintain buildings, fixtures, and other physical facilities of plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required by 21 CFR 117.35(a).
    • Failed to have adequate sanitary facilities and accommodation for trash disposal, as required by 21 CFR 117.37(f).
    • Failed to conduct operations in accordance with adequate sanitation principles and take adequate precautions to ensure that production procedures did not contribute to allergen cross-contact and to contamination, as required by 21 CFR 117.80(a)(1) and (4).
    • Failed to ensure that cleaning compounds and sanitizing agents are safe and adequate under the conditions of use, as required by 117.35(b)(1).
    • Failed to have equipment and utensils that were designed and constructed to be adequately cleanable and maintained to protect against allergen cross-contact and contamination, as required by 21 CFR 117.40.

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  • Vinill Inc., Brooklyn, NY – violations include:
    • Failed to conduct a hazard analysis for products that are produced to determine whether there are food safety hazards that are reasonably likely to occur. And failed to have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b).
  • Best Nutrition Products, Inc., Hayward, CA – violations include:
    • Failed to establish written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553, and to have qualified personnel conduct a review and investigation of product complaints, as required by 21 CFR 111.560.
    • Failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453.
    • Failed to establish and follow written procedures to fulfill the requirements related to returned dietary supplements, as required by 21 CFR 111.503.
    • Failed to establish and follow written procedures for cleaning the physical plant and grounds and for pest control, as required by 21 CFR 111.16.
  • Rose Acre Farms, Inc., Seymour, IN – violations include:
    • Failed to take appropriate measures to achieve satisfactory rodent control when monitoring indicated unacceptable rodent activity, as required by 21 CFR 118.4(c)(1).
  • Samuel Zimmerman, Penn Yan, NY – violations include:
    • Failed to have and implement a written Salmonella Enteritidis prevention plan (“SE Plan”), as required by 21 CFR 118.4.
    • Failed to use appropriate rodent monitoring methods as required by 21 CFR 118.4(c)(1).
    • Failed to use appropriate monitoring methods to monitor for flies, as required by 21 CFR 118.4(c)(2).
    • Failed to conduct environmental testing for SE in the poultry house when laying hens are 40 to 45 weeks of age, as required by 21 CFR 118.5(a).
    • Failed to maintain records in accordance with 21 CFR 118.10, which includes recordkeeping requirements for a Salmonella Enteritidis (SE) prevention plan.
  • Environmental Trade Inc., Eatonton, GA – violations include:
    • Products are adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they bear or contain a poisonous or deleterious substance which may render such products injurious to health.
  • Natural Sea Product Co., Muang Samut Sakhon, Thailand – violations include:
    • Failed to conduct a hazard analysis for products that are produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1).

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About the Author

Patty Harvey

Patty Harvey, a nationally recognized food expert and speaker, is the Food Product Manager at FDAzilla. Patty joins FDAzilla from PL Harvey Consulting, LLC where she continues to consult for the world’s top food companies.

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