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WARNING LETTER

Dreamland Trading Inc MARCS-CMS 499656 —


Recipient:
Dreamland Trading Inc


United States

Issuing Office:
Minneapolis District Office

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142 

 

June 29, 2016
 
 
WARNING LETTER
 
 
Via Hand Delivery                                                             
Refer to MIN 16 - 13
 
 
Mohamed Mohamed
Owner
DreamLand Trading, Inc.
3912 Dight Avenue South
Minneapolis, Minnesota  55406-3244
 
Dear Mr. Mohamed:
 
The Food and Drug Administration (FDA) conducted an inspection of your food storage warehouse and distribution facility located at 3912 Dight Avenue South, Minneapolis, Minnesota, from April 29 to May 18, 2016.  Our inspection found your firm is a warehouse and distributor of imported food products including, but not limited to, rice, pasta, packaged juices, edible oils, tea, spices, and dates.  
 
The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These violations cause the food products held in your facility to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. § 342(a)(4), because they are held under insanitary conditions whereby they may have been contaminated with filth or may have been rendered injurious to health. You can find the FD&C Act and the CGMP regulations through links on FDA’s website at www.fda.gov. On May 6, 2016, the Minnesota Department of Agriculture (MDA) placed an embargo on food products held in your facility.
 
Our investigators provided you with a form FDA 483, Inspectional Observations, at the close of the inspection on May 18, 2016. We acknowledge Saleh M. Jeylani’s May 24, 2016, DreamLand Trading Corrective Action Plan (CAP) and, in response to FDA’s June 3 and June 17, 2016, letters covering matters related to the food products under MDA’s embargo, CAP revisions submitted on June 9 and June 23, 2016. The investigators observed the following conditions and practices during the inspection of your facility:
 
1.    You failed to take effective measures to exclude pests and to protect against contamination of food by pests on the premises, as required by 21 CFR 110.35(c). Specifically:
 
A.  Gaps were observed on four overhead dock doors and two man doors in both the North and South Warehouses; daylight was observed beneath each gap:
 
1.    The dock door in the North Warehouse had a 1” visible gap at the sweep floor juncture along the whole length of the door.
2.    The usable dock door in the South Warehouse had a 1” visible gap near the northeast side where the door was damaged.
3.    The man door located on the north wall of North Warehouse, and shared with an adjacent auto mechanic business, had a 1½” visible gap.
4.    The two dock doors blocked by pallets of product in the South Warehouse had visibly damaged sweeps.
5.    The man door located on the south wall of the South Warehouse had a ¼” visible gap.
 
B.  On April 29, 2016, the investigators observed a dead mouse on sticky paper against the south wall of the North Warehouse. In addition, the investigators observed rodent excreta pellets (REP), confirmed by FDA analysis, in the following locations within your warehouse:
 
1.    more than 75 REP in the SW corner of the North Warehouse where Basmati Rice was stored;
2.    more than 60 REP on the floor along the north wall at the man door;
3.    more than 40 REP and spilled rice on the floor between pallets of Basmati Rice located between rows near the south wall of the North Warehouse;
4.    more than 25 REP and spilled rice on the planking of an upper pallet of Basmati Rice and on rice bags located against the south wall of the North Warehouse;
5.    6 REP on pallet planking and an apparent gnaw hole in a bag of Basmati Rice along the south wall of the North Warehouse;
6.    more than 15 REP and spilled rice within the shrink wrap of a pallet of Aged Rice located along the north wall of the South Warehouse;
7.    more than 8 REP within the shrink wrap on a pallet of Aged Rice located along the north wall of the South Warehouse.
 
C.  On May 3, 2016, the investigators examined a pallet of Basmati Rice from India, packaged in 20-lb brown‑colored bags coded as PACKING DATE 01/2015 EXPIRY DATE 01/2017, located in the North Warehouse, two rows from the south wall, and found:
 
1.    40 REP and nesting material on layer 1;
2.    27 REP on layer 2;
3.    25 REP on layer 3;
4.    25 REP and a gnaw hole on layer 4;
5.    35 REP and a gnaw hole on layer 5;
6.    95 REP on the floor west of the pallet;
7.    more than 70 REP on the floor south of the pallet.
 
The investigators examined a second pallet of Basmati Rice from India, packaged in 20-lb brown‑colored bags coded as PACKING DATE 01/2015 EXPIRY DATE 01/2017, located in the North Warehouse against the south wall and found:
 
8.    119 REP and a gnaw hole on layer 1;
9.    more than 50 REP on layer 2;
10.    more than 70 REP on layer 3;
11.    more than 90 REP and a gnaw hole on layer 4;
12.    more than 25 REP on the floor between the south wall and the pallet;
13.    8 REP on the floor east of the man door on the north wall.
 
D.  On May 6, 2016, the investigators observed a gnaw hole, 6 REP, and spilled rice between the shrink wrap and outer bags of Aged Rice located along an aisle in the South Warehouse
 
E.  On May 11, 2016, the investigators examined a pallet of Aged Rice from Pakistan, packaged in 10-lb white‑colored bags coded as PACKING DATE 06/2014 EXPIRY DATE 06/2016, located in the South Warehouse, against the north wall, and found:
 
1.    16 REP on layer 2;
2.    45 REP and 3 gnaw holes on layer 3;
3.    37 REP on layer 4;
4.    93 REP and a gnaw hole on layer 5;
5.    73 REP on layer 6.
 
The investigators observed the following throughout the North and South Warehouses:
 
6.    30 REP on pallet planking and bags of Aged Rice along the south wall of South Warehouse;
7.    12 REP on pallet planking of packaged pasta and along south wall of South Warehouse;
8.    4 REP on pallet planking of bottled juice and along the floor of the south wall of South Warehouse;
9.    22 REP along floor by the man door in the southwest corner of the South Warehouse;
10.    31 REP on pallet planking and the slip sheet of juice containers along south wall of South Warehouse;
11.    16 REP on pallet planking of pomace oil and along the floor on the south side aisle of North Warehouse;
12.    6 REP along the floor in the southwest corner of the North Warehouse;
13.    6 REP on the floor and on pallet planking holding yellow bags of Basmati Rice located along north wall of the North Warehouse.
 
We acknowledge that Mr. Jeylani stated during the inspection that he had sealed the gap under the man door on the north wall of the North Warehouse, replaced the door sweeps on the overhead door, and had the exterminator service the facility for rodents. Despite these corrections, the investigators observed daylight between the bottom of the doors and the concrete aprons when the doors were shut.
 
2.    You failed to store finished food under conditions that protect against deterioration of the food and its container, as required by 21 CFR 110.93. Specifically, our investigators observed: 
 
A.  pallets holding stored food had inadequate space between pallets and walls, which does not allow for proper sanitation, pest control, or access to these areas for inspection;
 
B.  dates packaged in metal cans were damaged and leaking;
 
C.  packages of pasta were observed open and stored inadequately outside of the original case packaging;
 
D.  product cases showed evidence of damaged and leaking contents;
 
E.  product cases were stored directly on the floor;
 
F.  clothing, empty wrappers, shrink wrap, rubbish, and totes of documents and tools were stored on cases of food products.
 
3.    You failed to provide adequate lighting in areas where food is examined, stored, or processed, as required by 21 CFR 110.20(b)(5). Specifically, the motion lights located at the east end, middle section of the North Warehouse were not working on May 3 and May 6, 2016.
 
We acknowledge corrective actions to which you committed in the CAP, including regular inspections and reports from a pest control company, inspections of all doors for signs of daylight or any other gaps for unwanted access, placing trash containers for proper disposal of waste, regular sweeping and mopping of floors, maintaining proper lighting. You stated that these activities will take place after the release of the embargo by MDA, and the destruction and reconditioning process is completed under the supervision of your GMP consultant. Your CAP failed to address the actions you will take to prevent recurrence of the violations.
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products or the conditions under which your products are stored. You are responsible for investigating and determining the causes of the violations identified above 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 and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
 
Section 743 of the Act, 21 U.S.C. § 379j-31, authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re‑inspection-related costs.  A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved.  Re‑inspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re‑inspection‑related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the FD&C Act. Accordingly, FDA may assess fees to cover any re‑inspection‑related costs.
 
Please respond to this office in writing within 15 working days from your receipt of this letter.  In your response, identify the procedures you have taken or will take to completely correct the current violations and to prevent them from recurring. In your response, please include the timeframe in which the corrections will be completed and provide documentation that will effectively assist us in evaluating whether the corrections have been made and are adequate. If you are unable to complete the corrective actions within 15 working days, identify the reason for the delay and the time within which you will complete the corrections.
 
Please send your reply to the Food and Drug Administration, Attention: Dr. Brian D. Garthwaite, Compliance Officer, at the address listed in the heading of this letter. If you have questions regarding any issue in this letter, please contact Dr. Garthwaite at (612) 758-7132.
 
Sincerely,
/S/ 
Michael Dutcher, DVM
Director
Minneapolis District

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