FDA Sent These 2 Warning Letters for Food Companies | August 2018

/, FDA Enforcement News, FDA Inspections, FDA Warning Letters, Food, FSMA/FDA Sent These 2 Warning Letters for Food Companies | August 2018

FDA Sent These 2 Warning Letters for Food Companies | August 2018

By | 2018-09-25T20:24:50+00:00 September 25th, 2018|CGMP, FDA Enforcement News, FDA Inspections, FDA Warning Letters, Food, FSMA|

We took a snapshot of the 2 warning letters the FDA sent to food companies last month. Food violations ranged from illegally selling an animal for slaughter to selling new “drugs” without FDA approval.

From companies in Nebraska and Wisconsin, here they are:

  • Dolezal Dairy, Pender, NE – violations include:
    • Offering for sale an animal for slaughter as food that was adulterated.
    • Holding animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply.
    • Lacking an adequate system to ensure that medicated animals have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues.

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  • Celletech, Ltd., Madison, WI – violations include:
    • Claims on website and on labels establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA.
    • Products are not generally recognized as safe and effective for the referenced uses.

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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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