FDA sends warnings to companies for Listeria in facilities, import violations

As part of its enforcement activities, the Food and Drug Administration issues warning letters to entities under its jurisdiction. Some letters are not displayed to the public until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters are often not issued until a company has had months or even years to correct the issues.


Sun Sen Co. Inc.
Sacramento, California

A California food company has been warned after environmental samples taken by FDA investigators tested positive for Listeria. The company was also cited for other serious violations.

In an August 17, 2022 warning letter, the FDA described the March 28-30, 2022 and April 11, 2022 inspections of Sun Sen Co. Inc. in Sacramento, California.

FDA inspection revealed serious violations of regulations relating to standards for growing, harvesting, packaging, and storing products for human consumption and resulted in the issuance of an FDA Form 483 . The significant violations are as follows:

Produce security policy violations

During the inspection, FDA investigators observed the following significant violations:

1. The company has not established or implemented a written environmental monitoring plan designed to identify species of Listeria or Listeria monocytogenes if present in the growing, harvesting, packaging and holding environment in accordance with the requirements. On April 11, 2022, the company told the FDA investigator that it had not established such a written plan and had never tested the environment for growing, harvesting, packaging and storing the germs for Listeria or Listeria monocytogenes species. This deviation from the PSR has already been discussed with them during the inspections conducted on July 26, 2018 and August 3, 2021. On April 11, 2022, at the end of the current inspection, they declared their intention to create a plan written for environmental sample and contact an accredited laboratory to begin monitoring for Listeria species or Listeria monocytogenes in their growing, processing, packaging and sprout holding areas. However, they have provided no evidence to support the remedies they are proposing.

2. The company failed to take the actions listed in 21 CFR 112.146, after its growing, harvesting, packaging, or holding environment tested positive for Listeria species or Listeria monocytogenes. On March 28, 2022, FDA investigators took environmental samples. Analysis of these samples identified Listeria seeligeri in one of 102 environmental swabs. Sub 28 was collected from a common surface between their metal germ wash tank and the outer metal surface in their germ growth chamber. On April 11, 2022, upon completion of the inspection, they stated that they had covered the area with a non-porous plastic drop sheet and would perform additional cleaning of the area. They provided no evidence to support their proposed corrective actions. Additionally, their proposed corrective action does not include additional testing of surfaces and surrounding areas, cleaning and disinfecting affected surfaces, performing additional sampling to determine if Listeria seeligeri has been eliminated, and other actions. necessary to prevent the recurrence of contamination if necessary. .

3. The company has not established or implemented a written sampling plan to test sprout-depleted (SSIW) irrigation water or sprouts being treated for pathogens as specified and in accordance with regulations. On April 11, 2022, they told FDA investigators that they had not collected and tested a sample of SSIW, or sprouts being processed, since their involvement in a sprouting seed supplier recall in 2004. This deviation from the PSR has already been discussed with the, during inspections conducted on July 26, 2018 and August 3, 2021. On April 11, 2022, at the end of the current inspection, they stated that they establish a written SSIW sampling plan and contact an accredited laboratory to begin collecting an SSIW or in-process sprout sample from each production batch of alfalfa and clover sprouts. However, they did not provide any evidence to support their proposed actions.

4. The company has not properly cleaned and disinfected the food contact surfaces it uses to grow, harvest, package or store sprouts before any contact with the sprouts or the seeds or beans used to make grow sprouts, as needed. During the most recent inspection, FDA investigators observed:

  • About 10 impure (redacted) perforated bins used to hold alfalfa and clover sprouts being processed, washed and ready to use, stacked inside each other.
  • Four dirty wire mesh screens located inside the (redacted) identified as “2 West”. On March 29, 2022, they said this grow unit was cleaned in accordance with company sanitation procedures. After cleaning, their sprout production worker then placed alfalfa seeds (lot #SAL2-20GJ) and purple clover seeds (lot #SCL2-21BJ) into a (redacted) identified as “(redacted)to germinate and grow within this unclean culture unit.

The company’s failure to clean and sanitize food contact surfaces in accordance with the PSR was already discussed with them during the inspection conducted on August 3, 2021.

Additionally, on March 28, 2022, the company told FDA investigators that their method of cleaning and disinfecting involves scrubbing and then rinsing food contact surfaces with an undiluted concentration of (redacted). The company’s inadequate sanitation practices and the use of a disinfectant agent instead of conducting cleaning activities were also discussed at a regulatory meeting on December 15, 2021.

5. The company has not established or kept documentation of the date and method of cleaning and disinfecting equipment, as required. On March 28, 2022, they explained to FDA investigators that they had not established and did not maintain documentation of when and how they cleaned and disinfected food contact equipment and tools used in the growing, harvesting, processing and packaging of alfalfa and cloverleaf. This deviation from the PSR had already been discussed with them during the inspections carried out on July 26, 2018 and August 3, 2021.

6. Company personnel failed to use the sanitation practices listed in 21 CFR 112.32. On March 28 and 29, 2022, FDA investigators observed employees touching non-food contact surfaces, including personal clothing, a cell phone, the end cold room plastic strip curtain south and a pallet truck. The same employees were then observed harvesting, washing and packing alfalfa and clover sprouts without changing gloves or washing their hands. On April 11, 2022, upon completion of the inspection, they stated that they will implement an employee training program. However, they provided no evidence to support their proposed corrective actions.

7. Company has failed to adequately train personnel who handle (contact) covered products or food contact surfaces, and personnel who perform covered activities, as required. They said they had not successfully completed food safety training at least equivalent to that received through a standardized curriculum recognized as adequate by the United States Food and Drug Administration. Additionally, they stated that they currently have (redacted) full time and (redacted) part-time employees who received no training when they were hired, nor any training since. On April 11, 2022, upon completion of the inspection, they stated that they will implement an employee training program. However, they did not provide any evidence to support this proposed remedy.

The full warning letter can be viewed here.

Visvita Corporation
Fullerton, California

An import company in California is warned by the FDA that it does not have an FSVP for a number of imported food products.

In an August 23, 2022 warning letter, the FDA described an April 26, 2022 Foreign Supplier Verification Program (FSVP) inspection of Visvita Corporation in Santa Fe Springs, California.

The FDA inspection revealed that the company was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. Significant offenses are:

The company has not developed, maintained and followed an FSVP as required. Specifically, they have not developed FSVPs for any of the food products they import, including each of the following foods:

  • Visvita Chia Beverage – Guanabana flavor imported from (redacted)situated in (redacted).
  • Aloe Vera drink – Pomegranate flavor imported from (redacted)situated in (redacted).
  • Cold Brew coffee powder imported from (redacted)situated in (redacted).

The full warning letter can be viewed here.

Distributors Mercado Hispano, LLC
Tucker, Georgia

An import company in Georgia is notified by the FDA that it does not have an FSVP for a number of imported food products.

In an August 2, 2022 warning letter, the FDA described a Foreign Supplier Verification Program (FSVP) inspection from February 23 to March 23, 2022 of Mercado Hispano Distributors, LLC in Tucker, GA.

The FDA inspection revealed that the company was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. Significant offenses are:

The company has not developed, maintained and followed an FSVP as required. Specifically, they have not developed FSVPs for any of the food products they import, including each of the following foods:

  • (Redacted) cola and (redacted) Manzana imported from (redacted)situated in (redacted)
  • (Redacted) Grapefruit imported from (redacted)situated in (redacted)

The full warning letter can be viewed here.

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