FDA Sent These 6 Warning Letters to Food Companies | May 2018

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FDA Sent These 6 Warning Letters to Food Companies | May 2018

By | 2018-06-11T15:06:09+00:00 June 11th, 2018|CGMP, FDA Warning Letters, Food, FSMA|

We took a snapshot of the 6 warning letters the FDA sent to food companies last month. Food violations ranged from companies failing to have personnel conform to hygienic practices while on duty to companies failing to clean and sanitize utensils.

From companies in the Carolinas, New York, and more, here they are:

  • Performance Nutrition Formulators LLC d.b.a. VMI Sports, Hicksville, NY – 3 violations:
    • Failed to establish and follow written procedures for the responsibilities of quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103.
    • Failed to have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement for distribution (21 CFR 111.127(h) and 21 CFR 111.140(b)(2).
    • Failed to establish and follow written procedures for holding and distributing operations, including written procedures for holding dietary supplements under appropriate conditions of temperature, humidity, or light so that the identity, purity, strength, and composition of the dietary supplements are not affected, as required by 21 CFR 111.455(a).

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  • Fair Fish Co., Inc., Bronx, NY – 4 violations:
    • Failed to take an appropriate corrective action when a deviation from a critical limit occurs to comply with 21 CFR 123.7(a).
    • Failed to have a HACCP plan that at a minimum lists the critical limits that must be met, to comply with 21 CFR123.6 (c)(3).
    • Failed to have HACCP corrective actions comply with 21 CFR123.7(b).
    • Failed to review critical control point monitoring records within one week after the records were made, to ensure compliance with 21 CFR 123.8(a)(3).
  • Liquidcaffeine.com – 1 violation:
    • Product is adulterated within the meaning of section 402(f)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(f)(1)(A)(i)] because it is a dietary supplement that presents a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling.
  • Dual Health Body and Mind, Statesville, NC – 1 violation:
    • Product is adulterated within the meaning of section 402(f)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(f)(1)(A)(i)] because it is a dietary supplement that presents a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling.
  • Orangeburg Pecan Company, Inc., Orangeburg, SC – 5 violations:
    • Failed to exclude pests from food plant to protect against contamination of food, as required by 21 CFR 117.35(c).
    • Failed to have all persons working in direct contact with food, food-contact surfaces, and food-packaging materials must conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, as required by 21 CFR 117.10(b).
    • Failed to clean all food-contact surfaces, including utensils and food-contact surfaces of equipment, as frequently as necessary to protect against contamination of food, as required by 21 CFR 117.35(d).
    • Failed to ensure that seams on food-contact surfaces are smoothly bonded or maintained so as to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms, as required by 21 CFR 117.40(b).
    • Failed to maintain buildings, fixtures, and other physical facilities of plant in repair adequate to prevent food from becoming adulterated, as required by 21 CFR 117.35(a).
  • New England Confectionery Company, Inc., Revere, MA – 5 violations:
    • Failed to take effective measures to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the contamination of food on the premises by pests as required by 21 CFR 117.35(c).
    • Failed to maintain buildings, fixtures, and other physical facilities in 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 clean and sanitize utensils and equipment in a manner that protects against the contamination of food as required by 21 CFR 117.35(d).
    • Failed to clean non-food contact surfaces as frequently as necessary to protect against contamination as required by 21 CFR 117.35(e).
    • Failed to have equipment and utensils that were designed and constructed to be adequately cleaned or maintained to protect against contamination as required by 21 CFR 117.40.

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at sales@fdazilla.com.

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About the Author

Paul Brooks

Paul Brooks is the lead FSMA/Food Business Development Representative at FDAzilla.

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