Thursday, September 29, 2022

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

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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.


Sun Sen Co. Inc.
Sacramento, CA

A food firm in California is on notice after environmental samples collected by FDA investigators tested positive for Listeria. The company was also cited for other serious violations.

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

The FDA’s inspection revealed serious violations of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption regulation and resulted in the issuance of an FDA Form 483. The significant violations are as follows:

Produce Safety Rule Violations

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

1. The firm did not establish and implement a written environmental monitoring plan that is designed to identify Listeria species or Listeria monocytogenes if it is present in the growing, harvesting, packing, and holding environment in accordance with requirements. On April 11, 2022, the firm told the FDA investigator that they have not established such a written plan and have never tested the sprout growing, harvesting, packing, and holding environment for Listeria species or Listeria monocytogenes. This deviation from the PSR was previously discussed with them during inspections conducted on July 26, 2018, and Aug. 3, 2021. On April 11, 2022, at the conclusion of the current inspection, they stated their intent to create a written plan for environmental sampling and to contact an accredited lab to begin monitoring for Listeria species or Listeria monocytogenes in their sprout growing, processing, packaging, and holding areas. However, they have not provided any evidence in support of their proposed corrective actions.

2. The firm did not take the actions listed in 21 CFR 112.146, after their growing, harvesting, packing, or holding environment tested positive for Listeria species or Listeria monocytogenes. On March 28, 2022, FDA investigators collected environmental samples. Analysis of these samples identified Listeria seeligeri in one of 102 environmental swabs. Sub 28 was collected from a joint surface between their metal sprout wash tank and metal exterior surface within their sprout growing room. On April 11, 2022, at the conclusion of the inspection, they stated that they have covered the area with a non-porous plastic sheet protector and would perform additional cleaning of the area. They have not provided any evidence in support of their proposed corrective action. In addition, their proposed corrective action does not include additional testing of surfaces and surrounding areas, cleaning and sanitizing the affected surfaces, conducting additional sampling to determine whether Listeria seeligeri has been eliminated, and other actions necessary to prevent the recurrence of the contamination as required.

3. The firm did not establish and implement a written sampling plan to test spent sprout irrigation water (SSIW) or in-process sprouts for pathogens as specified and in accordance with regulation. On April 11, 2022, they told FDA investigators that they have not collected and tested a SSIW sample, or in-process sprouts, since their involvement in a sprouting seed supplier recall in 2004. This deviation from the PSR was previously discussed with the, during inspections conducted on July 26, 2018, and Aug. 3, 2021. On April 11, 2022, at the conclusion of the current inspection, they stated that they will establish a written SSIW sampling plan and will contact an accredited lab to begin collecting an SSIW sample or in-process sprouts from each production batch of alfalfa and clover sprouts. However, they have not provided any evidence in support of their proposed actions.

4. The firm did not appropriately clean and sanitize food contact surfaces they use to grow, harvest, pack, or hold sprouts before contact with sprouts or seeds or beans used to grow sprouts as required. During the most recent inspection, FDA investigators observed:

  • Approximately 10 unclean (redacted) perforated bins used to hold in-process, washed, and RTE alfalfa and clover sprouts being stacked inside of one another.
  • Four unclean metal mesh screens located inside the (redacted) identified as “2 West”. On March 29, 2022, they stated this growing unit had been cleaned in accordance with the firm’s sanitation procedures. Following cleaning, their sprout production employee then placed alfalfa seeds (Lot #SAL2-20GJ) and clover crimson seeds (Lot #SCL2-21BJ) inside a (redacted) identified as “(redacted)” to be germinated and grown inside this unclean growing unit.

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

In addition, on March 28, 2022, the firm told FDA investigators that their method of cleaning and sanitizing consists of scrubbing and subsequently rinsing food-contact surfaces using an undiluted concentration of (redacted). The firm’s inadequate sanitation practices and use of a sanitizing agent in place of conducting cleaning activities were also discussed during a regulatory meeting on Dec. 15, 2021.

5. The firm did not establish and keep documentation of the date and method of cleaning and sanitizing of equipment as required. On March 28, 2022, they explained to FDA investigators that they did not establish and do not maintain documentation of the date and method of cleaning and sanitizing of food contact equipment and tools used in the growing, harvesting, processing, and packing of alfalfa and clover sprouts. This deviation from the PSR was previously discussed with them during inspections conducted on July 26, 2018, and Aug. 3, 2021.

6. Personnel at the firm did not use hygienic 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 cellphone, the south end cold storage room plastic strip curtain, and a pallet jack. The same employees were then observed harvesting, washing, and packing alfalfa and clover sprouts without changing their gloves or washing their hands. On April 11, 2022, at the conclusion of the inspection, they stated that they will implement an employee training program. However, they have not provided any evidence in support of their proposed corrective action.

7. The firm did not appropriately train personnel who handle (contact) covered produce or food contact surfaces, and personnel who conduct covered activities, as required. They stated that they have not successfully completed a food safety training at least equivalent to what is received under a standardized curriculum recognized as adequate by the U.S. Food and Drug Administration. In addition, they stated that they currently have (redacted) full-time and (redacted) part-time employees who did not receive any training upon hire, or any training since. On April 11, 2022, at the conclusion of the inspection, they stated that they will implement an employee training program. However, they have not provided any evidence in support of this proposed corrective action.

The full warning letter can be viewed here.

Visvita Corporation
Fullerton, CA

An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.

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

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 as required. Specifically, they did not develop an FSVP for any of the food products they import, including each of the following foods:

  • Visvita Chia Drink – Guanabana Flavour imported from (redacted), located in (redacted).
  • Aloe Vera Drink – Pomegranate Flavor imported from (redacted), located in (redacted).
  • Cold Brew Coffee Powder imported from (redacted), located in (redacted).

The full warning letter can be viewed here.

Mercado Hispano Distributors, LLC
Tucker, GA

An import company in Georgia is on notice from the FDA for not having FSVPs for a number of imported food products.

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

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 as required. Specifically, they did not develop an FSVP for any of the food products they import, including each of the following foods:

  • (Redacted) Cola and (redacted) Manzana imported from (redacted), located in (redacted)
  • (Redacted) Grapefruit imported from (redacted), located in (redacted)

The full warning letter can be viewed here.

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