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FDA warning letters include violations with juice, dairy cows

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A variety of violations of federal laws are the topic of warning letters recently sent to food companies by the U.S. Food and Drug Administration.

Following are details of warnings sent to companies in late March and made public in recent days by the FDA.

Kostechka Dairy LLC, Whitelaw, WI — FDA inspected the dairy operation on Dec. 3 and 29, 2015, and found two animal drugs had not been administered to cows per the label directions without the supervision of a licensed veterinarian. The drugs, ceftiofur hydrochloride and Lincomycin-Spectinomycin, were administered for unapproved durations and/or frequencies.

The FDA also found that drugs were given to lactating dairy cows without following the animal class as stated on the prescription label, also without the supervision of a licensed veterinarian.

P & L Distributor Inc. dba Asia World Food Wholesale Co., West Valley City, UT — FDA inspected the operation Nov. 19-24, 2015, and found serious violations of the FDA’s Current Good Manufacturing Practice (cGMP) in the Manufacturing, Packing, or Holding Human Food.

“These conditions cause the products being held at your facility to be adulterated in that your food products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health,” according to the warning letter.

Specific cGMP violations included:

  • failure to maintain the building, fixtures, and other physical facilities in a sanitary condition. For example, spilled powders and liquids and loose, degrading food were observed throughout the facility. Damaged, torn containers exposed food products to the environment. In addition, the overall organization and storage of food products prevented adequate cleaning;
  • failure to take effective measures to exclude pests from the storage areas. Specifically, evidence of bird and insect activity throughout, including bird feces and dead mite-like, spider-like, and worm-like insects; and
  • failure to provide adequate screening or other protection against pests. Specifically, a door was observed open and unattended for approximately two hours during the inspection and gaps were observed between doors and wall junctures of the loading dock door and glass doors.

“The observations noted during the November 2015 inspection were repeat observations from the July 2013 and January 2015 inspections indicating that a sound sanitation program has not been implemented and/or followed at your facility,” the FDA said in the March warning letter.

Post Winery Inc., Altus, AR — From Dec. 15-18, 2015, FDA inspected the juice manufacturing facility and found serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation. Specifically, the company’s HACCP plan had not been revised to reflect proper pasteurization temperatures for the company’s muscadine red, muscadine white and concord grape 100 percent juices.

The company’s HACCP plan fails to list how long its juices must be held at pasteurization temperatures to control Salmonella and E. coli bacteria. Also,  on specific dates in November and October, inadequate temperatures were used in the pasteurization process but no record of corrective actions was available.

Post Winery also failed to conduct a hazard analysis to determine safety hazards, according to FDA. Specifically, the company’s HACCP plan does not address the food safety hazards of sulfites, which it adds to its juices.

The company also does not have the required sanitation standard operating procedure records for a number of functions, including the safety of water that comes into contact with food; maintenance of hand washing and toilet facilities; protection of food and food packaging material from chemical and biological contaminants;  and proper labeling, storage and use of toxic compounds.

Derreck Maxey, Riesel, TX — The FDA inspected the animal dealer operation Dec. 7-14, 2015, and found that it had violated federal law by offering an animal for slaughter as food that was adulterated because it had drug residue in its tissue.

Specifically, tissue from a dairy cow sold for slaughter as food had 0.97 parts per million (ppm) of desfuroylceftiofur which is a marker residue of ceftiofur in the kidney and 26.02 ppm of oxytetracycline in the kidney. FDA allows only 0.4 ppm for desfuroylceftiofur and12 ppm for the sum of residues of the tetracyclines including oxytetracycline for residues in the kidney tissue of cattle.

“You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues.You failed to maintain treatment records; you lack an adequate inventory system for determining the quantities of drugs used to medicate your animals; and you failed to maintain records regarding the identity of and to record the existing identification of the animal(s) that you purchased and transported and delivered for sale,” according to the FDA warning letter.

Additionally, FDA’s investigation found that Maxey falsely signed a certification stating that the livestock he sells does not have illegal levels of drug residues, which is also a violation of federal law.

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