An import company in New Mexico is on notice from the FDA for not having food safety documents for a number of imported foods. The inspection was initiated because of an investigation of a multistate foodborne outbreak of Salmonella Oranienburg illnesses linked to whole, fresh onions imported from the state of Chihuahua, Mexico.

The outbreak has sickened more than 800 people in the United States and remains under investigation. The Centers for Disease and Prevention has not yet declared the outbreak over.

In its warning letter the Food and Drug Administration  acknowledged that the company initiated a voluntary recall on Oct. 22, 2021, of red, yellow, and white onions imported from its “suppliers (redacted)” in Chihuahua, Mexico, from July 1, 2021, through Aug. 25, 2021.

In the March 2, 2022, warning letter just made public by the FDA, the agency described a Nov. 16, 2021, Foreign Supplier Verification Program (FSVP) inspection of Keeler Family Farms in Deming, NM.

“We acknowledge that during the inspection, you informed our investigator that you would begin researching the FSVP requirements and would consider taking FSVP training to assist in developing FSVP records for all foreign suppliers. Furthermore, you stated that you would only use ‘Keeler Family Farms’ as the FSVP importer (FSVPI). Our records show that you continue to import covered foods, including alfalfa hay and fresh hot peppers, into the United States under various FSVPIs. To be in compliance with section 805 of the FD&C Act, you must develop an FSVP for each of the foods you import before importation of covered foods into the U.S.,” the FDA said in its warning letter.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations for any of the foods it imports from the Mexican state, and resulted in the issuance of an FDA Form 483a. One of the significant violations was:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:

  •  Fresh onions imported from their foreign suppliers, (redacted), located in Chihuahua, Mexico.

The FDA warned of possible additional action: “If you do not adequately address this matter, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food you import for which you appear to be in violation of section 805. We may place the foods you import from the identified foreign suppliers on detention without physical examination (DWPE) when you import the foods.”

The full warning letter can be viewed here.

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