The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. 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.

US Gulf Coast Trading Co. Inc.
Houston, TX

A food firm in Texas is on notice from the FDA of severe violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation. These violations include the presence of rodents, maggots and more.

In a Dec. 5, 2023, warning letter, the FDA described an Aug. 7-15, 2023, inspection of US Gulf Coast Trading Co. Inc.’s refrigerated, frozen, and ambient food product warehouse in Houston, TX. 

After the inspection, the FDA investigators issued an FDA Form 483, Inspectional Observations, listing deviations found at their facility. In addition, during the inspection, FDA collected filth samples from various areas within the warehouse facility, and the analytical results revealed rodent filth present throughout the facility.

Some of the significant violations are as follows:

Current Good Manufacturing Practice:

1. The firm did not exclude pests from their food plant to protect against contamination of food. Specifically, FDA investigators observed evidence of rodent activity, including rodent excreta pellets (REPs) in numbers too numerous to count (TNTC), gnaw marks in food and food packaging, nesting material, live maggots, and other apparent excrement throughout their facility, including areas wher human food is routinely stored. Below are some examples of the observations made by the investigators:

(Redacted) of the warehouse:

• On Aug. 7, 2023, more than 50 REPs were on the floor along the (redacted) bay door. Food products such as herbal tea, tortillas, pomegranate sauce, basmati rice, and dried mallow were stored within 3 feet of this door.
• On Aug. 7, 2023, TNTC REPs and seven other apparent excrements were in the (redacted) corner behind boxes containing packaged herbal tea stacked on a pallet.
• On Aug. 7, 2023, there were more than 100 REPs along the (redacted) wall behind a pallet containing boxes containing tortillas, loose tortillas, and pomegranate sauce.
• On Aug. 8, 2023, numerous REPs were placed on top of and along the seams of 20 lb. burlap bags containing long-grain steamed basmati rice, located in section (redacted).
• On Aug. 8, 2023, REPs, gnaw holes, and nesting materials on boxes and packaging containing dried mallow were located in the section (redacted).
• On Aug. 8, 2023, numerous REPs, rodent-gnawed material, and live maggots on and inside packages of tortillas were located in section (redacted).

(Redacted) of the warehouse:

• On Aug. 7, 2023, more than 50 REPs were behind a pallet of boxes containing jarred pickled cucumbers in the middle and on the bottom of a row (redacted).
• On Aug. 7, 2023, more than 50 REPs were behind a pallet containing boxed canned black olives in the middle bottom of the row (redacted).
• On Aug. 7, 2023, TNTC REPs at the (redacted) corner, adjacent to the office entry, and on a pallet containing instant noodles.
• On Aug. 7, 2023, approximately 20 REPs were on top of boxes containing white vinegar and tahini at the (redacted) end bottom of row (redacted).

(Redacted) of the warehouse:

• On Aug. 7, 2023, approximately 40 REPs were on the floor around a pallet containing packages of jarred jam and black olive slices at the (redacted) end, located on the bottom of the row (redacted).
• On Aug. 7, 2023, TNTC REPs were on the floor next to a pallet of packaged and jarred jam and black olives slices at the (redacted) end, located on the bottom of the row (redacted).
• On Aug. 9, 2023, TNTC maggots on, underneath, and behind a pallet containing canned pepper molasses, flavored rose water, canned liquid Jameed yogurt soup, and pomegranate sauce located in section (redacted).

(Redacted) of the warehouse:

• On Aug. 7, 2023, greater than 100 REPs were on top of two pallets containing packaged cooked chickpeas stored adjacent to the employee restroom.
• On Aug. 7, 2023, TNTC REPs behind the two pallets of cooked chickpeas stored adjacent to the employee restroom.

In addition to visual observations, FDA collected several samples during the inspection. These samples included food products and a filth sample. These samples were submitted to FDA labs for analysis, which confirmed the presence of REPs, rodent gnaw marks in the packaging, and/or rodent hairs in these samples. Further, the filth sample included REPs and rodent-gnawed materials collected from various warehouse areas, demonstrating that rodent activity existed throughout their facility.

2. The firm did not maintain its plant in adequate repair. Specifically, gaps were observed along the bottom (redacted) and top of the (redacted) bay door when the door was fully closed. The roll-up door opens directly to the exterior (redacted) of the warehouse, which could allow for the entrance of pests into the facility. Food products such as packaged tortillas (redacted), herbal tea, and stuffed eggplant were stored directly approximately 3 feet from this bay door.

3. The firm did not clean their non-food contact surface in a manner and as frequently as necessary to protect against allergen cross-contact and contamination. Specifically, the exterior wall of the refrigerator located at sections (redacted) and (redacted) of the warehouse was observed to contain streaks from a tahini spill. The tahini was observed spilled onto the product below, wall, and floor. The tahini product, which is made from sesame seeds, a known allergen, was stored on a rack above other products such as broad fava beans and a pallet that contained canned pepper molasses, flavored rose water, canned liquid yogurt soup, and pomegranate sauce.

4. The firm did not store food under conditions that protect against food contamination. Specifically, on Aug. 7-10 and 15, 2023, the (redacted) bay door, (redacted) bay door, and entry door into the warehouse in the (redacted) of the (redacted) wall remained open when not in use and for extended periods. These conditions could allow for the entrance of pests into their facility, which may cause contamination of food products stored inside the warehouse.

5. The firm did not keep the grounds around their plant in a condition that would protect against food contamination. Specifically, during the inspection, FDA investigators observed:

• On Aug. 7-10 and 15, 2023, numerous empty pallets being stored directly against the exterior corner of the (redacted) wall, directly adjacent to the (redacted) bay door, which remained open when not in use and for extended periods during the inspection.
• On Aug. 7-10 and 15, 2023, the grass and weeds located at the back and east side of the facility were observed to be overgrown, which may lead to the harborage of pests.

These conditions could allow for the contamination of food products stored inside the warehouse.

6. The firm did not store a toxic chemical in a manner that protects against contamination. Specifically, on Aug. 7-10, 2023, a container of insect killer was observed being stored directly adjacent to a pallet containing boxes of jarred jam and canned olives at the end of row (redacted) of the warehouse and 20 lb. sacks of steamed basmati rice approximately eight ft. away along the (redacted) wall of the warehouse.

The full warning letter can be viewed here.

Desserts by Helen Inc.
Louisville, KY

A food firm in Kentucky is on notice from the FDA for serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation. These violations include potential contamination through unwashed hands, mold, Listeria and more. 

In a Sept. 11, 2023, warning letter, the FDA described a Feb. 27 through March 13, 2023, inspection of Desserts by Helen Inc.’s ready-to-eat (RTE) bakery products manufacturing facility in Louisville, KY.

After the inspection, the FDA investigators issued an FDA Form 483, Inspectional Observations, listing deviations found at their facility. The significant violations are as follows:

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 wash hands thoroughly (and sanitize if necessary to protect against contamination with undesirable microorganisms) before starting work, after each absence from the workstation, and at any time when the hands may have become soiled or contaminated. Expressly, the following employee practices were noted on Feb. 28, 2023:

a. Two employees wearing gloves retrieved RTE chocolate cakes from the walk-in freezer. They touched the door handles, the interior surface of the walk-in freezer door, and plastic strip curtains that had a build-up of visible residue. The employees then touched the RTE chocolate cakes without washing and sanitizing their hands and changing their gloves. The employee then scooped chocolate sprinkles by hand, wearing the same gloves, and coated the cake with chocolate sprinkles.

b. During the RTE Mile High Chocolate Cake manufacturing, an employee moved a trash can using their gloved hands and then continued to apply chocolate sprinkles to the RTE cake without first washing and sanitizing their hands and changing their gloves.

2. The firm did not maintain buildings, fixtures, and other physical plant facilities in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated. Specifically, on Feb. 27 and 28, 2023, investigators observed the following conditions:

a. A metal storage shelf in the walk-in cooler was visibly unclean with a green and white substance, mold-like in appearance.

b. Apparent food residue and apparent green and white mold-like substance on a (redacted) plastic pallet located in the walk-in cooler. The (redacted) plastic pallet held a (redacted) bucket of “(redacted) WHOLE CHERRY FILLING.”

c. Standing brown liquid in the drainage basin located in the packaging room. The drainage basin also contained apparent dirt, concrete pieces, and pieces of cloth.

d. Pitted floors throughout the facility; they were visibly unclean and missing sealant in multiple areas. This is a repeat observation from FDA’s April 2022 inspection.

e. Unclean interior surfaces of the dishwashing machine with apparent mineral and food residue buildup. This is a repeat observation from FDA’s April 2022 inspection. Additionally, the water in the tank of the dishwashing machine was observed to contain food residue, which is circulated and sprayed over the dishes as part of the wash/rinse process.

3. The firm did not clean food contact surfaces, including equipment utensils and food-contact surfaces, as frequently as necessary to protect against allergen cross-contact and against contamination of food. Specifically, on Feb. 28, 2023, FDA investigators observed the following conditions:

a. Employees used a metal scoop and spatula stored in the drawers of a (redacted) toolbox that were visibly unclean with apparent food residue to apply icing to RTE Mile High Chocolate Cake without cleaning and sanitizing the utensils prior to use.

b. A buildup of food residue was observed on the interior sides and the slicing blade of the cake slicer used to slice RTE Jalapeno Cornbread in the packaging room.

4. The firm did not clean non-food-contact surfaces of equipment in a manner and as frequently as necessary to protect against allergen cross-contact and contamination of food, food-contact surfaces, and food-packaging materials. Specifically, on Feb. 28, 2023, FDA investigators observed the following conditions:

a. A buildup of food residue on the underside, spindle, and rear splash guard of the stand mixers being used to manufacture RTE chocolate buttercream icing and Jalapeno Cornbread batter.

b. Food residue on the base, underside, locking lever and wheels of the batter dispensing machine located in the production room used to manufacture RTE Jalapeno Cornbread batter.

c. Build-up of food residue on the top shelf extending over the stove, the stove’s backsplash, and the exhaust hood above the stove. An employee used the stove to melt margarine in a metal pot. This is a repeat observation from FDA’s April 2022 inspection.

d. Visibly unclean exteriors of various stand mixer bowls stored on metal shelving. An employee retrieved one such bowl and used it to manufacture a Jalapeno Cornbread batter without cleaning or sanitizing the bowl prior to use.

5. The firm plant is not constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and in good repair. Specifically, an area of approximately 75 square feet located behind the walk-in freezer is not accessible for cleaning, as the space is too narrow for someone to access. The floors and walls are visibly unclean from apparent dirt and cobwebs. This is a repeat observation from FDA’s April 2022 inspection.

In addition to the violations described above, the FDA offers the following comments:

• During FDA inspection, 80 environmental swabs were collected from various locations throughout their processing areas. FDA laboratory analysis of environmental sample 1204755 collected on Feb. 27, 2023, confirmed eleven swabs positive for Listeria innocua and two swabs positive for Listeria innocua/welshimeri, both non-pathogenic Listeria species. The positive findings include the drain in the basin of the packaging room wher our investigator observed standing brown liquid, on the floor next to exterior door in the production room, and middle of the floor of the basin located in the packaging room. FDA notes that the investigator observed floors that were pitted and visibly unclean throughout the facility and floors are potential sources of Listeria, especially wher there are cracks and crevices. Furthermore, during FDA’s previous inspection in April 2022, FDA laboratory analysis of environmental sample 1171554 consisting of fifty swabs collected on April 11, 2022, confirmed two swabs positive for Listeria innocua, one swab positive for Listeria ivanovii, and one swab positive for Listeria grayi. The presence of Listeria species such as Listeria innocua, welchimeri, ivanovii, grayi suggests that conditions also are suitable for survival and/or growth of Listeria monocytogenes, an environmental pathogen. As a manufacturer of RTE bakery products, the firm is responsible for ensuring that they have appropriate procedures and practices to prevent Listeria monocytogenes contamination in their facility.
• The firm must establish and maintain records that document their employees’ received training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the food, the facility, and the individual’s assigned duties.
• The firm’s facility meets the “qualified facility” definition under 21 CFR 117.3; therefore, they are subject to the modified requirements in 21 CFR 117.201 of the CGMP & PC rule. These modified requirements include the requirement that the facility submit a form to FDA attesting to the facility’s status as a qualified facility. In addition, they must attest that they have identified potential hazards associated with the food being produced, are implementing preventive controls to address hazards associated with the food being produced, and are monitoring the performance of the preventive controls to ensure that such controls are effective; or their facility is in compliance with State, local, or other non-Federal food safety law. To date, they have not submitted an attestation.

The full warning letter can be viewed here.