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.
Lucky K.T. Co., Inc.
El Monte, CA
The FDA has warned a food firm in California over various violations inside their manufacturing facility, including pests such as birds, rodents, worms and cockroaches.
In a Jan. 26 warning letter, the FDA described an April 18 through May 11, 2023 inspection of Lucky K.T. Co. Inc.’s food manufacturing facility in El Monte, CA.
The FDA’s inspection revealed that the firm was not in compliance with federal regulations, which resulted in the issuance of an FDA Form 483.
Some of the significant violations are as follows:
Hazard Analysis and Risk-Based Preventive Controls:
1. The firm did not prepare, or have prepared, and implement a food safety plan, as required. The preparation of the food safety plan must be overseen by one or more preventive controls qualified individuals (PCQIs), and their food safety plan must include the following:
- The written hazard analysis,
- The written preventive controls,
- The written supply-chain program,
- The written recall plan,
- The written procedures for monitoring the implementation of the preventive controls,
- The written corrective action procedures, and
- The written verification procedures.
Current Good Manufacturing Practice:
1. The firm did not take reasonable measures and precautions to ensure that all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against allergen cross-contact and against contamination of food. Specifically, the following was observed:
a. On April 30, 2023, employees returned from break to the Fresh Rice Noodle cutting and packaging area without washing their hands. One employee, responsible for folding the (redacted by FDA) Fresh Rice Noodle sheets, touched his ear and immediately handled the Fresh Rice Noodles with his bare hands. Other employees folded and carried stacks of cooked Fresh Rice Noodle sheets over their bare hands and forearms to prepare them for cutting and packaging.
b. On April 2026, 2023, two employees were packaging (redacted by FDA) Rice Stick Noodles while wearing their watches and rings. They were handling sheets of uncut and cut Rice Stick Noodles, bundling them, and grabbing them with their bare hands to place them into plastic bags. As the noodles are flexible, strands of noodles occasionally wrapped around the hands and wrists of the employees.
c. On April 20, 2023, an employee stored his cell phone on the worktable, directly adjacent to the Egg Noodles he was (redacted by FDA). The employee’s cell phone was covered in white powder and Egg Noodle.
d. On 4/26/2023, an employee with long arm hairs was weighing and packaging (redacted by FDA) Egg Noodles using his bare hands, and the noodles came into direct contact with his forearms.
e. On April 18, 2023, personal belongings, including a sweatshirt, two lunch bags, and a water bottle, were stored on the top surface of table where (redacted by FDA) Rice Stick Noodles are cut and packaged.
2. The firm’s equipment and utensils were not designed and constructed as to be adequately cleanable and were not adequately maintained to protect against allergen cross-contact and contamination. Specifically, the following were observed:
a. OnApril 19, 2023, an employee (redacted by FDA) Egg Noodles was placing rounds of (redacted) Egg Noodles directly on top of cardboard boxes, which had absorbed oil over time, and turned dark as a result.
b. On April 21, 2023, employees were (redacted by FDA) Pancit Noodles in a two-compartment sink filled with milky-colored water in order to (redacted by FDA) before packaging. Employees then transferred the noodles to a tall, white plastic container, filled with milky-colored water, (redacted by FDA). The plastic container contained black and brown residues and showed signs of abrasion and cracking. The (redacted by FDA) Pancit Noodles were (redacted by FDA).
c. On April 26, 2023, a pot, submerged in a bucket containing (redacted by FDA) and (redacted by FDA), was used to measure and add the mixture into Mixer Tank (redacted by FDA) of the Rice Stick Noodle (redacted by FDA). The handle of the pot, which appeared to be rusted, was also partially (redacted by FDA).
d. On May 10, 2023, the interior of the wash tank in the Fresh Rice Noodle line, used for (redacted) and (redacted) rice in water, had a crusty build-up of white, black, and yellow residue. The buildup was most apparent on the uneven seams of the wash tank. They stated the employees had already washed this line.
3. The firm did not clean all food-contact surfaces, including utensils and food-contact surfaces of equipment as frequently as necessary to protect against allergen cross-contact and against contamination of food. Specifically, the following were observed:
a. On April 18, 2023, there was an orange-colored residue on the surface of the water pump inside the rice (redacted by FDA) tank of the Rice Stick Noodle line. The tank was filled with water and rice, submerging the water pump, and exposing the rice to the orange residue.
b. On April 18, 2023, there was a white-colored buildup on the pipes, electrical tubing, and water tubing in and around the wash tank and grinder of the Rice Stick Noodle line. The pipes and tubes came into direct contact with the rice and water. Additionally, water droplets from spraying water were forming and dripping from these pipes and tubes, directly above exposed (redacted by FDA) rice and (redacted by FDA).
c. On April 19, 2023, a dirty copper water pipe was submerged inside rice and water in the rice (redacted) tank; a rusty release lever was located approximately 4 inches above the grinder hopper of the wash tank, over exposed rice; and the grinder hopper containing rice appeared rusted or deteriorated.
d. On April 21, 2023, a white buildup was observed on the surface of a 2-compartment sink immediately before an employee began washing and (redacted by FDA) Pancit Noodles in the sink. Further, there was a brown residue along the wall directly connected to the sink, greenish buildup along the base of the faucet, a yellow residue on the faucet knobs, and a dirty hose submerged in one of the compartments filled with water for cleaning the noodles.
e. On April 21, 2023, two employees were weighing (redacted) Pancit Noodles with (redacted) tabletop scales that had pink and brown-colored residue adhering to the face of the scale dial and underneath the scale plate. The back of the scale had a white and orange buildup and rusty screws, and the scales appeared to have peeling paint, deep seams, and discolored surfaces. The piles of noodles on the table, and the noodles being weighed, all came into direct contact with the scale surfaces.
f. On May 10, 2023, an employee was rinsing Egg Noodles (redacted by FDA) them, in a sink that had brown/black residue adhering to the edges. The noodles were placed into the sink filled with water and they came into contact with the unclean surfaces of the sink while being removed.
g. On May 10, 2023, Egg Noodles were hanging out of, and touching, the dirty exterior of the white bins they were being held in (redacted by FDA). Additionally, the white bins were stacked on top of each other on a (redacted by FDA) covered with yellow, white, and black build-up, and strands of Egg Noodles hanging out of the white bins came in contact with the dirty cart.
4. The firm did not exclude pests from their food plant to protect against contamination of food. Specifically, the following were observed:
a. On April 18, 2023, throughout the day, at least 5 apparent birds were flying in the warehouse, rice noodle production area, and egg noodle production area.
b. On April 18, 2023, at least 10 apparent winged insects were crawling on the walls adjacent to the rice wash tank and inside the exhaust vents directly above Mixer Tanks (redacted by FDA) and (redacted by FDA) of the Rice Stick Noodle line.
c. On April 19, 2023, a hole in the wall, less than a foot away from the rice soak tank of the Rice Stick Noodle line, contained remnants of old rice and apparent worm-like insects.
d. OnApril 19, 2023, at least 3 apparent cockroach-like insects were hiding amidst the electrical wiring structure of the wash tank, located adjacent to the rice grinder and directly above the rice soak tanks. On the same day, 1 apparent cockroach-like insect was dead, on top of the rice (redacted), directly beneath the electrical tubing.
e. On April, 19, 2023, at least 4 apparent birds flew out from behind the Pancit/Egg Noodle (redacted by FDA) equipment. The roll-up door was fully open, and the side door to the outside was slightly open, during various times throughout the day. On the night of 4/19-20/2023, the loading door was left open by employees. They closed the door when it was pointed out by our investigator, but it was later found wide open again.
f. On April 19, 2023, at least 1 apparent bird was observed walking around the noodle frying station, where both packaged and unpackaged deep-fried noodles were sitting atop cardboard boxes.
g. On April 26, 2023, 1 apparent dead mouse was observed between pallets of (redacted) and (redacted by FDA) in the raw material warehouse.
5. The firm did not maintain their plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated.
a. Walls and ceilings (area greater than (redacted by FDA)) adjacent to and directly above the rice stick noodle soak tanks and wash tank had yellow and brown buildup adhering to them.
b. The floors throughout the facility, in walkways, and directly beneath and adjacent to processing equipment, are pitted and cracked.
c. There was a pink, yellow, and brown buildup on an area of the floor, approximately (redacted by FDA) in size, located behind the rice grinder of the Rice Stick Noodle line.
d. The walls and floors adjacent to the 2-compartment wash sink and Fresh Rice Noodle wash tank had a brown and yellow buildup.
e. The walls and floors adjacent to the 2-compartment wash sink in the Egg Noodle room had apparent yellow and brown buildup.
6. The firm did not properly store equipment, remove litter and waste, and cut weeds and grass within the immediate vicinity of the plant that may constitute an attractant, breeding place, or harborage for pests within the immediate vicinity of the plant. Specifically, the following were observed:
a. The exterior facility walls had an over-growth of vegetation. Specifically, on the exterior wall containing the pedestrian door and loading dock door of the Egg Noodle production room, there was an overgrowth of plants above the pedestrian door, and both doors were left open during employee breaks and production breaks.
b. The uncovered trash bins outside of the facility in the front parking lot contained food waste, and on ay 10, /2023, at least 7 birds were eating from scraps around the trash bins.
The full warning letter can be viewed here.
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