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
Evansville, IN
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.

The FDA also initiated additional site inspections of the firm’s pet food 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:

Aflatoxins
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.

Salmonella Recontamination
The firm’s written food safety program hazard analyses for its Oklahoma, New York, Indiana, and Illinois facilities determined that the known or reasonably foreseeable hazard of Salmonella spp. in (redacted) made of (redacted) is a hazard requiring a preventive control. The (redacted), which is identified (redacted) controlling Salmonella spp. in ingredients at the product (redacted). The firm’s FSPs identify their (redacted) (i.e., portions of a Salmonella-positive lot undergo additional testing (redacted) for (redacted).

For example, the firm collected samples from the following nine lots of finished pet food products manufactured at their Illinois facility between (redacted).

In-house analysis found these samples to be presumptively Salmonella positive and they were subsequently confirmed positive by the firm’s third-party laboratory. However, under its (redacted) control, the company distributed into interstate commerce portions of Salmonella positive pet food lots.

A (redacted) does not control the Salmonella hazard in the liquid outside coatings.

Therefore, the firm failed to implement a preventive control to provide assurance that the Salmonella spp. hazard is significantly minimized or prevented and that the pet food manufactured at their facilities will not be adulterated.

General evaluation of the firm’s responses and corrective actions
The FDA acknowledges the firm’s voluntary recalls of adulterated products contaminated with aflatoxin and Salmonella. However, recalling products does not prevent the reoccurrence of a hazard in the company’s pet food. It is the firm’s responsibility to prevent adulterated products from entering the animal food supply through a robust hazard analysis and risk-based preventive controls program.

The full warning letter can be viewed here.

Transu Investment Group, LLC
Richardson, TX
An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.

In a July 16 warning letter, the FDA described a Feb. 26 to March 5, 2021, Foreign Supplier Verification Program (FSVP) inspection of Transu Investment Group LLC in Richardson, TX.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. Two of the significant violations are as follows:

• Specifically, for the firm’s pineapple syrup and red beans from (redacted) and their honey syrup from (redacted), they did not determine and document which verification activity or activities, as well as the frequency with which the activity or activities must be conducted, are needed to provide adequate assurances that the food you obtain from the foreign supplier is produced.
• The firm must verify and document that the food was produced in accordance with 21 CFR part 113. However, it did not verify and document that their red beans from (redacted) were produced in accordance with 21 CFR part 113.

The full warning letter can be viewed here.

Productos Bredy USA LLC
Houston
An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.

In an Aug. 3 warning letter, the FDA described a March 11 to 16 Foreign Supplier Verification Program (FSVP) inspection of Productos Bredy USA LLC in Houston.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for any of the food products they import, including their (redacted) soft drinks imported from (redacted), located in (redacted).

The full warning letter can be viewed here.

YemenUSA Inc.
Detroit, MI
An import company in Michigan is on notice from the FDA for not having FSVPs for a number of imported food products.

In a July 22 warning letter, the FDA described a May 4 to 14 Foreign Supplier Verification Program (FSVP) inspection of YemenUSA Inc. in Detroit, MI.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:

• The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop, maintain, and follow an FSVP for any of the foods they import, including the black pepper powder and raisins they import from their foreign supplier Yassin Spices, located in Yemen.

The full warning letter can be viewed here.