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Current Position:Home » News » Law & Regulation » International Regulations » Topic

FDA warning letters: Rodents, bugs, seafood HACCP violations and drug residues

Zoom in font  Zoom out font Published: 2016-06-21  Views: 105
Core Tip: The U.S. Food and Drug Administration (FDA) recently sent warning letters to a food distribution warehouse in Minnesota, a bakery in California, and a beef operation in Iowa.
 The U.S. Food and Drug Administration (FDA) recently sent warning letters to a food distribution warehouse in Minnesota, a bakery in California, and a beef operation in Iowa.
 
AMJ Distribution Company Inc. of Brooklyn Park, MN, had its warehouse and food product distribution facility, which handles corn, millet, seeds and ready-to-eat dried/smoked seafood products, inspected by FDA from March 24 to April 13, 2016.
 
FDAWarningcolor_406x250In a warning letter dated June 7, 2016, the agency told the company that the inspection “revealed serious violations” of Current Good Manufacturing Practice (CGMP) regulations.
 
“The violations included significant evidence of rodent activity and insanitary conditions throughout your facility,” the letter stated, including the demonstrated presence of rodent excreta pellets and rodent hair, rodent gnawing and rodent urine, and also the adult head of a sawtoothed grain beetle and the presence of a merchant grain beetle and Chalcid wasps.
 
The failure to take effective measures to exclude pests as required by federal law renders the company’s products adulterated, FDA stated. Also cited as problems at the facility were rubbish and piles and bags of non-food items in and around stored products.
 
FDA’s warning letter also noted “significant” seafood HACCP violations due to the lack of a hazard analysis for each kind of fish and fishery product the company produces, which is required under federal regulations.
 
“However, your firm does not have a HACCP plan for your ready-to-eat smoked/dried pike and catfish, dried boney fish, snails, and fish powder to control food safety hazards which may include allergens, pathogen growth, and toxin formation, e.g. Staphylococcus aureus,” the letter stated.
 
Douce France Inc.  (dba, Douce France Bakery) in Redwood City, CA, was told in a warning letter dated May 19, 2016, that FDA’s inspection on Feb. 3-5, 2016, revealed violations of CGMPs at the company’s facility, which manufactures bread, dessert pastry and other bakery products.
 
Specifically, FDA stated that an employee was observed making a type of eggless bread with a mixer previously used to make products containing egg, an allergenic ingredient. Also, a knife used to cut cake was taken from a bucket apparently containing unclean water, the letter noted, and a metal sifter with “protruding fraying pieces of metal mesh” was used to sift powdered sugar.
 
“Although this observation was brought to the attention of management on February 3, 2016, the same sifter was observed sitting on top of a powdered sugar container the next production day. Additionally, investigators observed that your firm does not have a metal detector,” FDA’s letter stated.
 
Cleaning and sanitizing operations at the facility were found to be inadequate, and employees working in direct contact with food and food-contact surfaces “did not conform to hygienic practices” while on duty sufficient to protect against contamination, according to the warning letter.
 
The bakery was also told that its tart shells were not labeled in accordance with FDA regulations in that the finished product fails to declare a major food allergen, milk, which FDA noted is in the butter used to make the product.
 
A June 3, 2016, warning letter sent to Scott and Eric Cherne of Guttenberg, IA, noted that investigators from FDA and the Iowa Department of Agriculture and Land Stewardship had visited their beef cow-calf operation on April 20-21, April 26-28, and May 2 and 4, 2016, and found violations of the Federal Food, Drug and Cosmetic Act.
 
The letter stated that a “Cherne Angus” cow was sold for slaughter as food on or about Feb. 22, 2016, and that analysis of tissue samples from this animal identified the presence of 3.91 parts per million (ppm) of Desfuroylceftiofur, a marker residue of certain drugs used to treat bacterial respiratory diseases in cattle and swine.
 
Since FDA has established a tolerance of 0.4 ppm for residues of Desfuroycleftiofur in the edible tissues of cattle, the presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated …,” FDA stated.
 
Recipients of these warning letters have 15 working days from receipt to outline specific steps they have taken to come into compliance with the law.
 
 
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