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FDA warning letters: Pests, seafood HACCP issues, drug residues

Sunday, October 2, 2016 22:22
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(Before It's News)

The most recently posted food-related warning letters from
the U.S. Food and Drug Administration went to a sprout
operation, two seafood importers, a seafood processor and two dairy

target="_blank">Chicago’s Indoor Garden
was sent a warning
letter on March 25 regarding an inspection FDA conducted from
May 11-14, 2015, at the company’s sprout operation at 4459 Division
St. in Chicago.

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the inspection, we documented insanitary conditions and practices
that render your green sprouts, wheatgrass, sunflower greens, pea
shoots, and sprouted beans adulterated” under the Federal Food,
Drug, and Cosmetic Act, FDA wrote.

Investigators observed rodent droppings, insect-like bore holes
in seed bags, and live and dead insects throughout the sprouting
operation, according to the warning letter.

Other problems cited were an employee “repeatedly wiping their
nose with a gloved hand and then returning to packaging finished
red clover sprouts without washing or changing the gloves or
washing their hands.”

FDA also noted that the firm soaks all seeds used to grow
ready-to-eat green sprouts, wheatgrass, sunflower greens, pea
shoots and beans without sanitizing chemicals or antimicrobial
treatment. The letter stated this was a repeat observation
documented during previous inspections in 2011 and 2012.

FDA recommends treating seeds for sprouting with one or
more treatments, such as 20,000 ppm calcium hypochlorite, that have
been approved for reduction of pathogens in seeds or sprouts, the
letter pointed out.

The agency stated that condensate from the evaporator unit was
observed actively dripping directly over uncovered bins of red
radish sprouts in the walk-in cooler.

“We recommend that you take appropriate steps to protect your
food from potential contamination from building surfaces through
condensation or drip from these or other surfaces,” FDA wrote.

The firm submitted corrective actions to FDA on May 28, 2015,
but the agency found that the problems “have not been adequately

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sent a warning letter to ""
target="_blank">SuperValu Inc.
 on Sept. 20 to say that
“serious violations” of the seafood Hazard Analysis and Critical
Control Point (HACCP) regulations had been noted during an
inspection of its seafood processing facility in Denver, PA,
performed between Aug. 10 and 19.

The firm did not take corrective action to
control pathogenic bacterial growth or toxin formation when
its process for storing seafood products deviated at
a critical control point, FDA wrote, adding that an
investigator documented 21 instances of temperature abuse between
June 2 and Aug. 10.

“No corrective actions were documented in any of these
instances,” according to the warning letter.

The company’s response to this observation was deemed inadequate
because FDA stated that no evidence of testing or training was

In a warning letter dated Sept. 15, FDA told href=
target="_blank">Frontier Japan Inc.
 that its seafood
importer establishment in New York City had serious seafood HACCP
violations when it was inspected on July 14.

Imported fish must be processed under conditions that are
equivalent to those required of domestic processors, FDA wrote.
Because this did not occur, the firm’s imported fresh fillet
yellowtail fish are adulterated “in that it has been prepared,
packed, or held under insanitary conditions whereby it may have
been rendered injurious to health,” the letter stated.

target="_blank">Arcadia Trading Inc.
of Brooklyn, NY, was told
in a Sept. 14 warning letter that a July 6 and 7 inspection of its
seafood importing firm identified “serious violations” of the
federal regulations, rendering its refrigerated,
vacuum-packed, salted croaker adulterated under the law.

The company’s response dated July 22 was found to be inadequate,
FDA wrote, because it did not provide an adequate affirmative step
to make sure that the imported product is processed in accordance
with the seafood HACCP regulations.

“Your product specifications should state that the dried or
salted croaker fish will be fully eviscerated and processed in
accordance with Good Manufacturing Practices,” the agency’s letter

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Aug. 22, FDA wrote to ""
target="_blank">Varel Farms LLC
 about an investigation
conducted June 23-29 at its dairy operation in Bartelso, IL. The
letter stated that on or about Feb. 18, the farm sold a cow for
slaughter as food.

USDA analysis of tissue samples from this animal identified the
presence of desfuroylceftiofur, a marker residue for ceftiofur, in
the kidney tissue at a level of 21.47 parts per million, the agency
pointed out. However, FDA’s tolerance level is 0.4 ppm for residues
of desfuroylceftiofur in the edible tissues of a cow.

The investigation also revealed that the dairy operation failed
to maintain complete treatment records, according to the warning

A warning letter went out to ""
target="_blank">Tensen Dairies LLC
on June 17 to say that FDA
investigators had found violations of the Federal Food, Drug,
and Cosmetic Act during an investigation conducted Feb. 23 through
March 2 at the dairy operation in Effingham, IL.

On or about Oct. 14, 2015, Tensen Dairies sold a cow for
slaughter as food, FDA wrote. Analysis of tissue samples collected
from this animal identified the presence of ampicillin at .26 ppm
in the kidney tissue, according to the warning letter, while FDA
has established a tolerance of 0.01 ppm for residues of ampicillin
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, the
agency stated. A failure to maintain complete treatment
records was also mentioned.

Recipients of FDA warning letters have 15 working days from
receipt to respond with details of the procedures they have taken,
or will take, to correct the current violations and prevent them
from recurring.

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