FDA Sent These 4 Warning Letters for Food Companies | April 2018

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FDA Sent These 4 Warning Letters for Food Companies | April 2018

By | 2018-05-29T17:01:12+00:00 May 29th, 2018|CGMP, FDA Warning Letters, Food, FSMA|

We took a snapshot of the 4 warning letters the FDA sent to food companies last month. Food violations ranged from products containing a poisonous or deleterious substance to companies failing to have an HACCP plan.

From companies in Washington, Kansas, and more, here they are:

  • Arrow Reliance Inc., Tukwila, Washington – 1 violation:
    • Products are adulterated under section 402(a)(1) of the Act, which states that food is deemed to be adulterated if it bears or contains a poisonous or deleterious substance which may render it injurious to health.

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  • Amerigo Laboratories LLC, Lenexa, Kansas – 5 violations:
    • Products fail to bear adequate directions for their intended use and, therefore, these products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
    • Products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the products’ labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.
    • Products’ promotional brochures and website fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).
    • Labeling fails to declare the quantitative amount of thiamin using the correct unit of measure given in 21 CFR 101.9(c)(8)(iv) in accordance with 21 CFR 101.36(b)(2)(ii)(B).
    • Products fail to list the dietary ingredients in accordance with 21 CFR 101.36(c)(2).
  • MC Fish Company, Milton, Kentucky – 3 violations:
    • Failed to conduct a hazard analysis for each kind of fish and fishery product that is produced 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).
    • Failed to have a HACCP plan that, at a minimum, lists the critical limits that must be met to comply with 21 CFR 123.6 (c) (3).
    • Failed to implement the monitoring procedures and frequencies that are listed in HACCP plan to comply with 21 CFR 123.6.
  • Hood River Juice Company Inc., Hood River, Oregon – 2 violations:
    • Failed to have HACCP plan that has, at a minimum, a list of all food safety hazards that are reasonably likely to occur in order to comply with 21 CFR 120.8(b)(1).
    • Failed to monitor sanitation conditions and practices during processing with sufficient frequency to ensure conformance with good manufacturing practice regulations, as required by 21 CFR 120.6(b).

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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