FOOD SAFETY NEWS
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems. The FDA frequently redacts parts of warning letters posted for public view.
Midwestern Pet Food – “Failure to implement preventive control”
Midwestern Pet Food
A pet food company in Indiana is on notice from the FDA after an inspection of several of its manufacturing plants revealed a number of serious violations, including dangerous levels of aflatoxin and salmonella in pet food.
Midwestern’s pet food has been linked to contaminated food that may have caused more than 130 pet deaths and more than 220 pet illnesses. The FDA said the actual number of pet deaths and illnesses is likely because of under reporting.
In an Aug. 9 warning letter, the FDA described a Dec. 30, 2020 ,through Feb. 5, 2021, inspection of Midwestern Pet Food’s manufacturing facility in Chickasha, OK. This initial inspection was triggered by reports of illness and deaths in dogs that had eaten the firm’s SPORTMiX brand dry dog food.
[Products made by Midwestern Pet Food are sold under a wide range of brand names; check all pet food labels. – HH]
The FDA also initiated additional site inspections of Midwestern Pet Food’s manufacturing facilities located in
- Waverly, NY, Feb. 9 through 23, 2021.
- Evansville, IN, Feb. 1 through March 3, 2021.
- Monmouth, IL, Feb. 2 through April 16, 2021.
During the Illinois inspection, the firm recalled approximately 104 products of dry dog and cat diets made from Oct. 26, 2020, to Nov. 12, 2020, Feb. 1 to12, 2021, and March 15 to 19, 2021, because routine monitoring yielded Salmonella-positive results for pet foods manufactured on common equipment during those periods.
The FDA’s inspection revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483. The significant violations are as follows:
The firm’s written food safety plan (FSP) hazard analyses (HA) for the Oklahoma, New York, Indiana and Illinois facilities identified the known or reasonably foreseeable hazard of aflatoxin in incoming corn and corn products as a hazard requiring a preventive control.
Aflatoxins are toxins produced by the mold Aspergillus flavus, which can grow on corn and other grains used as ingredients in pet food. At high levels, aflatoxins can cause illness and death in pets.
According to each FSP, their the company’s control is “Aflatoxin inhouse testing” with an acceptance parameter for aflatoxin in corn and corn products at receiving (redacted), with any incoming corn or corn products (redacted) or greater to be rejected.
However, the firm’s facilities failed to follow proper sample preparation procedures, as outlined in the aflatoxin test kit manufacturer’s recommended procedure, referenced USDA Mycotoxin Handbook, and/or facility-defined procedures that its facilities reported as being followed. This led to potentially inaccurate analyses and test results for sampled products.
Failure to implement the preventive control was further evidenced by sixteen samples of their Oklahoma facility’s finished SPORTMiX cat and dog food products collected by FDA and state counterparts. These samples were found to contain elevated levels of aflatoxin from 21.5 ppb to 558 ppb, levels that FDA has determined to be harmful in dog and cat food.
The preventive control they established to control the aflatoxin hazard at their facilities was not properly implemented and therefore was ineffective at significantly minimizing or preventing the hazard of aflatoxin and did not provide assurance that the pet food manufactured at their facility will not be adulterated … READ MORE.
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