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  5. Victory Trading Company Inc. - 651799 - 04/17/2023
  1. Warning Letters

WARNING LETTER

Victory Trading Company Inc. MARCS-CMS 651799 —


Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages

Recipient:
Recipient Name
Linh T. Tran
Recipient Title
Owner
Victory Trading Company Inc.

1634 Greenland Road
Greenland, NH 03840-2247
United States

Issuing Office:
Division of Human and Animal Food Operations East I

United States


WARNING LETTER
CMS # 651799

Dear Mr. Tran:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your ambient, refrigerated, and frozen food warehouse located at 1634 Greenland Road, Greenland, NH 03840, from December 12, 2022 to January 13, 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), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). At the conclusion of the inspection, FDA issued an FDA Form-483 (FDA-483), Inspectional Observations, listing deviations found during our inspection. 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 inspectional and analytical findings, we determined the food products held in your facility are adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] in that they have been 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 further information relating to the CGMP & PC rule and your responsibilities to comply with this and other FDA regulations through links on FDA’s web page at https://www.fda.gov.

Your firm voluntarily destroyed the (b)(4) pallets of rice that were (b)(7)(A); however, to date, we have not received your written response to the issued FDA-483 describing corrective actions taken or planned by your firm to correct the identified deficiencies. Based on our review of the inspectional and analytical findings, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility.
We found the following significant violations:

Current Good Manufacturing Practice (21 CFR Part 117, Subpart B)

1. You did not take effective measures to exclude pests from your holding areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 117.35(c). Specifically, rodent activity was observed throughout your warehouse facility including the following:

Rodent Activity observed

(b)(4)

  • On December 12, 2022, during a bag-by-bag examination of (b)(4) pallets of (b)(4) White Rice, lot # “(b)(4)”, stored in the (b)(4) corner of your warehouse, apparent rodent excreta pellets (REPs) too numerous to count (TNTC), apparent rodent gnaw holes in the bags of rice, and yellow stains on the bags of rice which smelled like urine and fluoresced UV light. An additional (b)(4) pallets of (b)(4) White Rice had an odor of urine and apparent REPs.
  • On December 13, 2022, an apparent decomposed dead rodent in the (b)(4) corner of the warehouse outside the big cooler.
  • On December 19, 2022, an apparent decomposed dead rodent in the (b)(4) corner of the warehouse outside the freezer.
  • On December 15, 2022, apparent REPs TNTC on an empty pallet in pallet location (b)(4) in the center of the (b)(4) area of the warehouse.
  • On December 15, 2022, approximately 10 apparent REPs on the floor below a pallet of bagged dried chili peppers among apparent rodent gnawed material in pallet location (b)(4) in the center of the (b)(4) area of the warehouse.
  • On December 15, 2022, apparent REPs TNTC on the floor behind a pallet of dried noodles in pallet location (b)(4) in the center of the (b)(4) area of the warehouse.
  • On December 15, 2022, approximately 15 apparent REPs on a pallet of BBQ sauce, and apparent rodent urine stains and apparent nesting materials on the floor directly next to pallet in pallet location (b)(4) in the center of the (b)(4) side of the warehouse.
  • On December 15, 2022, approximately 6 apparent REPs on a pallet of plastic cups in pallet location (b)(4) in the center of the (b)(4) side of the warehouse. The pallet also appeared to contain apparent rodent urine stains, and boxes of cups appeared to have bird excreta on them.
  • On December 15, 2022, approximately 13 apparent REPs on the floor in pallet location (b)(4) in the center of the (b)(4) side of the warehouse.

(b)(4)

  • On December 14, 2022, two apparent dead rodents in a glue trap in the (b)(4) corner of the warehouse.
  • On December 14, 2022, an apparent dead rodent in a glue trap along the (b)(4) wall of the warehouse under racks of bags of powdered drink mixes and seeds in pallet location (b)(4).
  • On December 14, 2022, an apparent dead rodent in a glue trap in the (b)(4) corner of the warehouse underneath racks of bagged powdered drink mixes in pallet location (b)(4).
  • On December 14, 2022, apparent REPs TNTC on the floor at the corner junction of the (b)(4) wall of the (b)(4) area of the warehouse directly next to pallet location (b)(4).
  • On December 14, 2022, apparent REPs TNTC on the floor along the (b)(4) wall of the (b)(4) corner of the warehouse in pallet location (b)(4).
  • On December 14, 2022, apparent REPs on the floor along the (b)(4) wall of the (b)(4) corner of the warehouse in pallet location (b)(4).

(b)(4)

  • On December 15, 2022, an apparent decomposed dead rodent on the floor along the (b)(4) wall of the warehouse where bagged rice was stored.
  • On December 15, 2022, apparent REPs TNTC on the floor and support beams along the back (b)(4) wall where bagged rice was being stored.
  • On December 13, 2022, apparent REPs TNTC and apparent nesting material observed in the (b)(4) section of the warehouse on the floor touching and directly next to pallets of (b)(4) White Rice.
  • On December 14, 2022, apparent REPs on the floor in the (b)(4) area of the warehouse (next to the employee bathroom) in pallet location (b)(4).
  • On December 14, 2022, apparent REPs and apparent rodent urine stains which fluoresced under UV light along the (b)(4) wall of the (b)(4) area of the warehouse in pallet location (b)(4).
  • On December 14, 2022, apparent REPs on the floor in the (b)(4) corner of the (b)(4) area of warehouse in pallet location (b)(4).
  • On December 14, 2022, approximately 6 REPs on the floor directly next to a pallet of rice sticks in pallet location (b)(4) in racks along the (b)(4) wall of the (b)(4) side of the warehouse.
  • On December 14, 2022, approximately 20 apparent REPs on a pallet of vinegar in pallet location (b)(4) in racks along the (b)(4) wall of the (b)(4) side of the warehouse.
  • On December 14, 2022, approximately 5 apparent REPs on the floor approximately 6” from a pallet of maltose in pallet location (b)(4) in racks along the (b)(4) wall of the (b)(4) side of the warehouse.
  • On December 14, 2022, apparent REPs TNTC on a pallet which contained jasmine tea in pallet location (b)(4) in storage racks along the (b)(4) wall in the (b)(4) side of the warehouse.
  • On December 15, 2022, apparent REPs TNTC on a pallet of plastic take-out containers in pallet location (b)(4) in storage racks along the (b)(4) wall in the (b)(4) side of the warehouse.
  • On December 14, 2022, approximately 20 apparent REPs on the floor scattered directly next to a pallet of dried seaweed in pallet location (b)(4) in storage racks along the (b)(4) wall in the (b)(4) side of the warehouse.
  • On December 14, 2022, a live insect and apparent REPs TNTC on a pallet of dried spices in pallet location (b)(4) in storage racks along the (b)(4) wall in the (b)(4) side of the warehouse.
  • On December 14, 2022, approximately 8 apparent REPs on a pallet of rice sticks in pallet location (b)(4) in storage racks along the (b)(4) wall in the (b)(4) side of the warehouse.

(b)(4)

  • On December 18, 2022, apparent REPs TNTC on the floor and on support beams along the (b)(4) wall behind coolers (b)(4) and (b)(4).
  • On December 19, 2022, approximately 10 apparent REPs on a table holding shrink wrap stored along the (b)(4) wall.
  • On December 19, 2022, approximately 15 REPs along the (b)(4) wall upstairs in the equipment storage room (b)(4) main office. Additionally, the rodent station (b)(4) was missing from its designated wall location.
  • On December 19, 2022, approximately 14 apparent REPs at the top corner of the stairs leading to the equipment storage room (b)(4) main office located at the (b)(4) wall of the warehouse.
  • On December 19, 2022, approximately 25 apparent REPs in the (b)(4) corner of the equipment storage room (b)(4) main office located at the (b)(4) wall of the warehouse.
  • On December 19, 2022, approximately 15 apparent REPs along the (b)(4) wall of the equipment storage room (b)(4) main office located at the (b)(4) wall of the warehouse.
  • On December 14, 2022, apparent REPs TNTC on the floor at the corner junction of the (b)(4) wall and the big cooler in the (b)(4) side of the warehouse where bagged sugar was being stored.
  • On December 19, 2022, approximately 2 apparent REPs on the floor in the walk-in freezer closest to the big cooler along the (b)(4) wall in the (b)(4) area of the warehouse.
  • On December 14, 2022, apparent REPs TNTC on the floor in the center aisle of the warehouse in pallet location (b)(4) of the (b)(4) area of the warehouse.
  • On December 14, 2022, approximately 11 apparent REPs on a pallet of (b)(4) noodles and approximately 15 REPS in a center food storage rack in the (b)(4) side of the warehouse in pallet location (b)(4).
  • On December 13, 2022, apparent REPs TNTC on a rack in pallet location (b)(4) and (b)(4) of the central aisle storage racks in the (b)(4) area of the warehouse used to hold (b)(4) Brown Rice in paper bags and (b)(4) Potato Starch in paper bags. Additionally, apparent rodent paw prints and tail marks were observed in spilled product on the racks.
  • On December 14, 2022, approximately 10 apparent REPs on the floor behind a pallet of bagged rice in pallet location (b)(4) of the central aisle storage racks in the (b)(4) area of the warehouse.
  • On December 14, 2022, apparent REPs on the floor along the (b)(4) wall of the (b)(4) area of the warehouse in pallet location (b)(4) directly below and next to bags of palleted rice.
  • On December 14, 2022, apparent REPs TNTC were observed on the floor along the (b)(4) wall and under a food storage rack on the left-hand sides of cooler (b)(4) in the (b)(4) area of the warehouse.

Samples
FDA collected several samples during the inspection. These samples included a food product sample (sample 1150377, (b)(4) White Rice) and filth samples (samples 1209822 and 1209823). These samples were submitted to FDA labs for analysis. Results demonstrate that the (b)(4) White Rice and sample 1209823 were contaminated with rodent excreta pellets (REPs), and sample 1209822 was contaminated with rodent excreta pellets and rodent nesting material. The filth samples further demonstrate the presence of rodents throughout the facility.

2. You did not maintain your plant in a clean and sanitary condition and keep your plant in repair adequate to prevent food from becoming adulterated, as required by 21 CFR 117.35(a). Specifically, insanitary conditions were observed throughout your facility demonstrating that sanitation, cleaning, and maintenance operations were inadequate. The following observations reflect potential areas for pest harborage and attractants for pests:

(b)(4)

  • On December 13, 2022, a 24" x 8" rip in the insulation liner of the (b)(4) wall exposing insulation. The exposed insulation had been partially removed and apparent REPs TNTC were observed inside the insulation.
  • On December 13, 2022, an approximate 1/4" hole through the wall to the outside and an approximate 12" x 12" rip in the insulation liner of the (b)(4) wall. An empty beer bottle was observed in the hole.
  • On December 15, 2022, an approximate 2-3” gap along the entire length of the (b)(4) wall creating a potential ingress for pests.
  • On December 15, 2022, an approximate 1” wide crack in the floor approximately 12” from pallet location (b)(4) creating a potential ingress for pests near the (b)(4) wall in the warehouse.
  • On December 15, 2022, an approximate ½” gap in the floor approximately 6” from pallet location (b)(4) in the (b)(4) area of the warehouse. There appeared to be hollow space beneath the gap.

(b)(4)

  • On December 13, 2022, two overhead doors on the (b)(4) side of the warehouse occupied by a moving and storage company were left open for an extended period during the day creating a potential ingress for pests.

(b)(4)

  • On December 13, 2022, spilled unknown white powder product on a pallet of soybean oil stored in the (b)(4) section of the warehouse.
  • On December 15, 2022, an approximate 1” gap closest to the (b)(4) wall of the warehouse creating a potential ingress for pests. The area below the gap appeared to be hollow.
  • On December 13, 2022, two approximate 1” gaps around electrical conduits in the (b)(4) wall of the warehouse creating an opening to the outside.

(b)(4)

  • On December 12, 2022, the plastic liner of the dividing wall in the center of the warehouse in the (b)(4) side contained what appeared to be rodent gnaw holes and apparent REPs inside the insulation in the wall. Apparent rodent nesting materials were observed on the ground, and gnaw marks were observed on a wooden post of the dividing wall.
  • On December 14, 2022, red onions in a bag made of plastic netting stored directly on the floor within 6” from where apparent REPs were observed outside the main office in the (b)(4) side of the warehouse.
  • On December 14, 2022, stagnant clear liquid on the floor of coolers (b)(4) and (b)(4) creating a potential attractant for pests and a potential harborage area for bacteria in the (b)(4) area of the warehouse.
  • On December 19, 2022, what appeared to be apparent rodent-gnawed material, apparent REPs TNTC, and insulation used as apparent rodent nesting material in the equipment storage trailer that is permanently affixed to the outside of the (b)(4) wall.

3. You did not maintain your facility’s grounds in a condition adequate to protect food from becoming contaminated, as required by 21 CFR 117.20(a)(1). Specifically, on December 14, 2022, an overgrowth of weeds and vegetation were observed outside on the eastern and northern sides of the warehouse, creating potential harborage areas for pests.

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. 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 FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Please respond in writing, within 15 working days of the receipt of this letter, of the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time frame within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Please send your reply to the Food and Drug Administration, Attention: Michael R. Dominick, Compliance Officer, 222 Bloomingdale Road, White Plains, NY 10605 or via email at Michael.Dominick@fda.hhs.gov (preferred). If you have any questions about the content of this letter, please contact Mr. Dominick at 914-682-2826 ext. 20 or email at Michael.Dominick@fda.hhs.gov.

Sincerely,
/S/

Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations East –
Division 1

 
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