As part of its enforcements, 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.

Kwokcheng Enterprise, Inc. dba Fullei Fresh

Miami, FL

The Food and Drug Administration sent a warning letter dated Oct. 22, 2019, to Kwok-Cheng Wong, President of Kwokcheng Enterprise, Inc. dba Fullei Fresh.

During an inspection from Jan. 28 to Mar. 11, 2019, FDA inspectors collected environmental samples from Kwokcheng Enterprise, Inc. dba Fullei Fresh’s sprouting operation. The samples were tested, and the presence of Listeria monocytogenes was identified. In response to these deviations, the FDA issued an FDA-483, Inspectional Observations that lists deviations observed at the sprouting operation.

The violations noted by the FDA include:

• “After your growing, harvesting, packing, or holding environment tested positive for Listeria species or monocytogenes, you did not conduct additional sampling and testing to determine whether the Listeria species or L. monocytogenes has been eliminated, as required by 21 CFR Part 112.146(c), and you did not perform any other actions necessary to prevent recurrence of the contamination, as required by 21 CFR Part 112.146(e).  Specifically, you received results from your environmental testing on December 14, 2018; January 9, 2019; and March 1, 2019; showing that your harvesting, packing, and holding environment tested positive for L. monocytogenes.  Additionally, some of your positive environmental samples were found in the same locations or on the same surfaces over time; for example, December 14, 2018; January 9, 2019; and March 1, 2019; reports all stated that the bean sprout packing table tested positive for L. monocytogenes.  During our inspection, we also tested your growing, harvesting, packing, and holding environment and found samples positive for L. monocytogenes, including one from the bean sprout packing table.  These findings demonstrate that L. monocytogenes was not eliminated from your growing, harvesting, packing, or holding environment and demonstrate the recurrence of L. monocytogenes contamination.”
• “You did not inspect, maintain, and clean, and, when necessary and appropriate, sanitize all food contact surfaces of equipment and tools used in covered activities as frequently as reasonably necessary to protect against contamination of covered produce, as required by 21 CFR Part 112.123(d)(1).  Specifically, during the inspection, our investigator observed that white and yellow buckets used to hold and store harvested bean sprouts were cracked, with dark scores and chips on areas of the buckets that touch the bean sprouts. The surface of these buckets had dark food residues in scored crevices.  Additionally, our investigator observed cracks and rough surfaces in the plastic panels inside the bean sprout growing bins. Our investigator observed that one of the cracks in the growing bins had adhesive tape applied to the crack as a repair. Our investigator also observed that the food contact surfaces of the blue conveyor belt used to transport harvested bean sprouts from the growing room to the packaging room was in disrepair, with a cracked, peeling surface and damaged and missing sections of material along the belt.”
• “You did not aseptically collect samples of spent irrigation water, as required per 21 CFR Part 112.147(b).  Specifically, our investigator observed a laboratory employee collecting spent irrigation water samples in a white tray placed under the flow of water from the growing bins. The employee then transferred the water into glass containers with plastic lids.  The white trays and other supplies were stored in a cart as the employee traveled through the operation but were open and not protected to prevent contamination from the environment.”

At the time the warning letter was sent, Kwokcheng Enterprise, Inc. dba Fullei Fres had provided a written response dated Mar. 21, 2019, outlining the corrective actions that they took in response to the environmental and product sample findings. The FDA responded in the letter, saying, “We acknowledge that you agreed on March 8, 2019, to recall a lot of your Organic Bean Sprouts. We also acknowledge that you have stated that you will more frequently monitor the environmental samples that you collect. We are unable to evaluate from your response, however, whether you conducted any extensive sampling or testing to verify that the contamination has been removed from your operation, including food contact surfaces and non-food contact surfaces.”

A complete list of the violations in the FDA warning letter.

About Listeria infections
Food contaminated with Listeria monocytogenes may not look or smell spoiled but can still cause serious and sometimes life-threatening infections. Anyone who has eaten any of the recalled products and developed symptoms of Listeria infection should seek medical treatment and tell their doctors about the possible Listeria exposure.

Also, anyone who has eaten any of the recalled products should monitor themselves for symptoms during the coming weeks because it can take up to 70 days after exposure to Listeria for symptoms of listeriosis to develop.

Symptoms of Listeria infection can include vomiting, nausea, persistent fever, muscle aches, severe headache, and neck stiffness. Specific laboratory tests are required to diagnose Listeria infections, which can mimic other illnesses.

Pregnant women, the elderly, young children, and people such as cancer patients who have weakened immune systems are particularly at risk of serious illnesses, life-threatening infections, and other complications. Although infected pregnant women may experience only mild, flu-like symptoms, their infections can lead to premature delivery, infection of the newborn, or even stillbirth.

Editor’s note originally posted Nov. 3: At this time, the credibility of the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) is not to be trusted. Both agencies have shown a reckless disregard for the public’s right to know, and their reliability going forward remains suspect. For the next six weeks, Food Safety News will publish this note above on every story involving the FDA or CDC.

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