WARNING LETTER
US Gulf Coast Trading Co., Inc.
MARCS-CMS 668767 —
December 05, 2023
Delivery Method:
UPS Overnight
Product:
Food & Beverages
Recipient:
Recipient Name
Abdallah K. Yassir
Recipient Title
Managing Partner and Co-Owner
US Gulf Coast Trading Co., Inc.
14100 Auto Park Way Ste. I
Houston
,
TX
77083-5887
United States
Issuing Office:
Division of Human and Animal Food Operations West III
United States
Secondary Issuing Offices
United States
December 5, 2023
WARNING LETTER
CMS #668767
Dear Mr. Yassir:
The United States Food and Drug Administration (FDA) inspected your refrigerated, frozen, and ambient food product warehouse located at 14100 Auto Park Way Ste. I, Houston, TX on August 7 through 15, 2023. During our inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule) in Title 21, Code of Regulations, Part 117 (21 CFR part 117). At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing deviations found at your firm. In addition, during the inspection, FDA collected filth samples from various areas within your warehouse facility, and the analytical results revealed rodent filth present throughout your facility.
Based on FDA’s inspectional findings, we have determined that the food products warehoused in your facility are adulterated within the meaning of section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(3)] because they consist in whole or in part of any filthy, putrid, or decomposed substance, or are otherwise unfit for food, and section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and FDA regulations through links in FDA's Internet home page at http://www.fda.gov.
We received your responses via email on August 22, 2023, and September 13, 2023, which included pest control reports, photos and video documenting the disposing of product in the dumpster, warehouse inspection sheets, and other warehouse photos. After reviewing the inspectional findings and responses that your firm provided, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility. We also address your responses below.
Current Good Manufacturing Practice (21 CFR part 117, Subpart B):
1. You did not exclude pests from your food plant to protect against contamination of food, as required by 21 CFR § 117.35(c). Specifically, our 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 your facility, including areas where human food is routinely stored. Below are some examples of the observations made by the investigators:
(b)(4)
of the warehouse:
On August 7, 2023, greater than 50 REPs on the floor along the
(b)(4)
bay door. Food products such as herbal tea, tortillas, pomegranate sauce, basmati rice, and dried mallow were stored within 3ft of this door.
On August 7, 2023, TNTC REPs and seven other apparent excrement in the
(b)(4)
corner, behind boxes containing packaged herbal tea stacked on a pallet.
On August 7, 2023, greater than 100 REPs along the
(b)(4)
wall behind a pallet containing boxes with tortillas, loose tortillas, and boxes containing pomegranate sauce.
On August 8, 2023, numerous REPs on top of and along seams of 20 lb. burlap bags containing long grain steamed basmati rice, located in section
(b)(4)
.
On August 8, 2023, REPs, gnaw holes, and nesting materials on boxes and packaging containing dried mallow, located in section
(b)(4)
.
On August 8, 2023, numerous REPs, rodent gnawed material, and live maggots on and inside packages of tortillas located in section
(b)(4)
.
(b)(4)
of the warehouse:
On August 7, 2023, greater than 50 REPs behind a pallet of boxes containing jarred pickled cucumbers in the middle and on the bottom of row
(b)(4)
.
On August 7, 2023, greater than 50 REPs behind a pallet containing boxed canned black olives in the middle bottom of row
(b)(4)
.
On August 7, 2023, TNTC REPs at the
(b)(4)
corner, adjacent to the office entry, and on a pallet containing instant noodles.
On August 7, 2023, approximately 20 REPs on top of boxes containing white vinegar and tahini at the
(b)(4)
end bottom of row
(b)(4)
.
(b)(4)
of the warehouse:
On August 7, 2023, approximately 40 REPs on the floor around a pallet containing packages of jarred jam and black olive slices at the
(b)(4)
end, located on the bottom of row
(b)(4)
.
On August 7, 2023, TNTC REPs on the floor next to a pallet of packaged and jarred jam and black olives slices at the
(b)(4)
end, located on the bottom of row
(b)(4)
.
On August 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
(b)(4)
.
(b)(4)
of the warehouse:
On August 7, 2023, greater than 100 REPs on top of two pallets containing packaged cooked chickpeas stored adjacent to the employee restroom.
On August 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 (samples 1231696, 1231697, and 1231698) and a filth sample (sample 1231695). 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 areas of the warehouse, demonstrating that rodent activity existed throughout your facility.
2. You did not maintain your plant in adequate repair, as required by 21 CFR § 117.35(a). Specifically, gaps were observed along the bottom,
(b)(4)
, and top of the
(b)(4)
bay door when the door was fully closed. The roll-up door opens directly to the exterior
(b)(4)
of the warehouse, which could allow for the entrance of pests into the facility. Food products such as packaged tortillas,
(b)(4)
, herbal tea, and stuffed eggplant were stored directly approximately 3 feet to this bay door.
3. You did not clean your non-food contact surface in a manner and as frequently as necessary to protect against allergen cross-contact and against contamination, as required by 21 CFR § 117.35(e). Specifically, the exterior wall of the refrigerator located at sections
(b)(4)
and
(b)(4)
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 which contained canned pepper molasses, flavored rose water, canned liquid yogurt soup, and pomegranate sauce.
4. You did not store food under conditions that protect against contamination of food, as required by 21 CFR § 117.93. Specifically, on August 7-10 and 15, 2023, the
(b)(4)
bay door,
(b)(4)
bay door, and entry door into the warehouse in the
(b)(4)
of the
(b)(4)
wall remained open when not in use and for extended periods. These conditions could allow for the entrance of pests into your facility, which may cause contamination of food products stored inside the warehouse.
5. You did not keep the grounds around your plant in a condition that would protect against the contamination of food, as required by 21 CFR § 117.20(a). Specifically, during the inspection, FDA investigators observed:
On August 7-10 and 15, 2023, numerous empty pallets being stored directly against the exterior corner of the
(b)(4)
wall, directly adjacent to the
(b)(4)
bay door, which remained open when not in use and for extended periods of time during the inspection.
On August 7-10 and 15, 2023, the grass and weeds located at the back and east side of the facility were observed to be overgrown that may lead to the harborage of pests.
These conditions could allow for the contamination of food products stored inside the warehouse.
6. You did not store a toxic chemical in a manner that protects against contamination, as required by 21 CFR § 117.35(b)(2). Specifically, on August 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
(b)(4)
of the warehouse and 20 lb. sacks of steamed basmati rice approximately 8 ft. away along the
(b)(4)
wall of the warehouse.
Your responses, dated August 21, 2023 and September 13, 2023, do not clearly demonstrate that your warehouse’s pest control issues are under control and the affected food products were voluntarily destroyed, the gaps in the warehouse doors have been repaired, the pallets have been removed, and the overgrown grass has been trimmed. Additionally, your facility’s most recent
(b)(4)
pest control report appears to only address “German Roaches” and “Crazy Ants” activity in the warehouse. There is no mention in the report regarding inspection for rodent activity or treatment/prevention services conducted for the control of rodents, e.g., placement of bait stations, bait replacement, monitoring, etc. Further, the technician documented in his report, dated
(b)(4)
, that your warehouse’s doors were left open during his visit, and he made a recommendation to keep the doors closed when not in use.
This letter is not intended to be an all-inclusive statement of violations that may exist in your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including applicable FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to adequately address this matter may result in legal action including, but not limited to, seizure and injunction.
Please notify FDA in writing within 15 working days of receipt of this letter, of the specific steps you have taken to correct violations, including an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that the food products warehoused in your facility are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time frame within which you will do so.
Your written response should be sent to René R. Ramirez, Compliance Officer, U.S. Food and Drug Administration, 1201 North Main Street, Suite 7200, Dallas, TX 75202. If you have questions regarding any issues in this letter, please contact Mr. Ramirez at rene.ramirez@fda.hhs.gov or (210) 308-1425.
Sincerely,
/S/
Edmundo Garcia, Jr.
Program Division Director HAF West 3
Cc: Texas Department of State Health Services
Lori Woznicki, M.P.H.
Food and Drug Inspections Branch Manager
1100 West 49th Street
Austin, TX 78756
Content current as of:
12/26/2023
Regulated Product(s)
Food & Beverages