FDA Warning Letters: Facility Problems, Unsafe Ingredients, Drug Residues

The latest batch of warning letters posted by the U.S. Food and Drug Administration (FDA) included one addressed to Frito-Lay Inc. of Plano, TX, concerning the “poor state of repair” of the company’s snack food manufacturing facility in Pulaski, TN.

The letter stated that an investigator from FDA who inspected the facility on May 26 and 27, and June 1, 2015, observed a number of problems.

These included peeling, chipping and missing paint; containers to collect water “due to apparent leaks in the roof” suspended from the ceiling and often directly over exposed product; worn and soiled equipment wash and sanitize bay, walls and floor; air duct work wrapped in plastic sheeting secured with duct tape over exposed food product; leaking water hose bib near processing equipment; areas of adhering product apparently leaking from two pipe connection points; apparent food product dripping from a leaking seal onto the floor; apparent corrosion and adhering debris on protective fan shrouds above ready-to-eat product, and apparent food debris and dust on interior walls and fixtures and mezzanine floors.

In addition, FDA’s letter stated that an employee on a processing line was observed “touching non-food contact surfaces, processing line framing, that appeared soiled with adhering food and then handling ready-to-eat product during processing and prior to packaging.”

Further, an employee was observed “wiping their hands on their pants, then resting hands on non-food contact processing line framing, and handling ready to eat product during processing and prior to packaging of product,” the letter stated.

FDA acknowledged Frito-Lay’s response, which included “a number of corrective actions” to modify or repair equipment and the building and stated that these would be verified as to their adequacy during the agency’s next inspection.

New Dawn Nutrition Inc. of Omaha, NE, was told that its dietary supplements,”NDN Ares Battle Ready Pre Workout” (Warpath Watermelon) and “NDN Ares Black” (Orange Overdose), contain dimethylbutylamine, also called 1,3 -Dimethylbutylamine, DMBA, 2-amino-4-methylpentane, AMP citrate, and 4-methyl-2-pentanamine, but which FDA calls DMBA.

Since DMBA has no history of use or other evidence of safety and since the company has not provided FDA with information concluding that its dietary supplements containing that ingredient “will reasonably be expected to be safe,” the agency stated that the products are considered adulterated under federal law. Additional problems relating to labeling and misbranding were also noted in the letter.

FDA told Nickerson Brothers of Arcade, NY, that a dairy cow slaughtered for food on or about Feb. 20, 2015, had 2.22 parts per million (ppm) of desfuroylceftiofur (marker residue for ceftiofur) in its kidney tissue. However, the federal tolerance level is 0.4 ppm for residues of desfuroylceftiofur in the target tissue (kidney) of cattle, the letter stated.

Sunland Dairy LLC of Phoenix, AZ, sold a dairy cow for slaughter as food on or about Feb. 9, 2015, whose kidney tissue samples later showed the presence of penicillin at 0.354 parts per million (ppm), FDA stated. The agency has established a tolerance of 0.05 ppm for residues of penicillin in the uncooked edible tissue, according to the warning letter.

A warning letter sent to MGM Cattle Co. Ltd. of Kingsbury, TX, noted that a cow sold for slaughter for food on or about Nov. 30, 2014, was later found to have 2.32 parts per million (ppm) of flunixin in the liver, 16.58 ppm of desfuroylceftiofur (marker residue for ceftiofur) in the kidney, and 0.31 ppm of florfenicol in the muscle.

However, FDA has established a tolerance of 125 parts per billion (ppb) (0.125 ppm) for residues of flunixin, 0.4 ppm for residues of desfuroylceftiofur, and 0.3 ppm of florfenicol in the edible tissues of cattle, respectively, according to the letter.

In addition, FDA noted, an employee of MGM Cattle Co. Ltd. provided a signed certification stating that livestock the company sells do not have illegal levels of drug residues. Providing such a “false guaranty” is prohibited by federal law, the letter stated, adding, “You should take appropriate actions to ensure that this violation does not recur.”

Gallman Farms of Mendon, OH, was informed that a FDA investigation showed that on or about March 25, 2015, a sow was sold as slaughter for food. On later analysis, the presence of pencillin was revealed in the animal’s kidney tissue, the letter stated.

“FDA has not established a tolerance for residues of penicillin in the edible tissues of swine …,” the agency noted, causing the food to be considered adulterated under federal law.

A warning letter sent to Garnett Livestock Inc. of Hereford, TX, stated that one of eight head of cattle the company sold for slaughter as food on or about Dec. 7, 2014, showed the presence of 0.46 parts per million (ppm) of desfuroylceftiofur (marker residue for ceftiofur) in kidney tissues following laboratory analysis. However, the FDA tolerance level is 0.4 ppm for residues of desfuroylceftiofur in the edible tissues of cattle, the letter noted.

In addition, the firm has “failed to inquire about the medication status of animals you purchase with intent to sell for slaughter for human food,” FDA stated, rendering any food from such animals adulterated.

In each letter, FDA requested that the companies provide written responses detailing steps taken to bring the facilities into compliance with food-safety laws and regulations, to correct violations cited in the letters, and to prevent their recurrence.

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.

Read More At: http://www.foodsafetynews.com/2015/08/fda-warning-letters-facility-problems-unsafe-ingredients-drug-residues/#.Vd66jCVViko

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