| Public Health Service Food and Drug Administration |
Seattle District |
Department of Health and Human Services
July 6, 2011
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 11-17
Mr. Kulwant Singh, Owner
Punjab Trading, Inc.
104 NW 49th Street, Suite 102
Auburn, Washington 98001-1742
WARNING LETTER
Dear Mr. Singh:
The Food and Drug Administration (FDA) conducted an inspection of your food storage and processing facility located at 104 NW 49th Street, Suite 102, Auburn, Washington, on February 15, 17, 22, 23 and 25, 2011. During the inspection, FDA investigators documented serious violations of the Current Good Manufacturing Practice regulations for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). The inspection revealed that food stored at your facility is adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that the food products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth.
In addition, sample # 667729 of Red Split Lentils, collected during the inspection, was analyzed by FDA’s Pacific Regional Laboratory Northwest. Laboratory analyses confirmed the presence of bird excreta on multiple bags of this product, and bird excreta in the contents of one (1) bag while held at your facility. The presence of bird excreta in your Red Split Lentils product causes the product to be 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)] in that it consists in whole or in part of a filthy, putrid, or decomposed substance, or is otherwise unfit for food. You can find the Act and its associated regulations on the internet through links on the FDA web page at www.fda.gov.
The following significant violations were observed during the inspection:
1. You failed to take effective measures to exclude pests from your facility and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically,
a. Our investigators observed live birds within your facility on February 17 and 22, 2011, including on and above stored, packaged food and wooden pallets used to hold bags and boxes of finished product.
b. Bird excreta and bird excreta stains were found within the North warehouse of your facility. Specifically, on February 22, 2011:
i. Bird excreta were on the outside surface of four/55 lb. poly-woven plastic bags and bird excreta stains were on the outside surface of two/55 lb. poly-woven plastic bags of Urid Gota located on a pallet along the South wall;
ii. Bird excreta were observed on the outside surface of one poly-woven 50 kg. plastic bag of black pepper located on a pallet along the South wall;
iii. Bird excreta and bird excreta stains were on the outside surface of one/25 kg. poly-woven plastic bag of chickpeas located on a pallet along the South wall;
iv. Bird excreta was on the outside surface of one/55.11 lb. poly-woven plastic bag of cumin seed spice located on a pallet below the fourth storage rack from the Northwest corner; and
v. Bird excreta was on a cardboard box about six inches from an opened 35 oz. bag of (b)(4) Papdi Chat Indian snacks located on a pallet below the third storage rack from the Northeast corner.
c. On February 17 and 22, 2011, bird excreta were on the bottom shelf of the pallet rack holding finished product and bird excreta were on the floor below the rack located in the Northeast corner of the North warehouse.
d. Bird excreta and bird excreta stains were observed within the South warehouse of your facility on February 23, 2011. Specifically:
i. Bird excreta stain and bird excreta were on the outside surface of two/25 kg. poly-weave plastic bags of split lentils and bird excreta was on plastic wrap surrounding a pallet of red split lentils located on the fourth pallet from the Northwest corner along the North wall;
ii. Bird excreta were on nine of the (b)(4) wood pallets stacked in the Southwest corner;
iii. A bird excreta was on the outside surface of a 25 kg. burlap bag of Whole Urd and bird excreta was observed on the outside of plastic wrap surrounding a pallet of Whole Urd located on the sixth pallet from the Northwest corner along the North wall; and
iv. Bird excreta were on cardboard boxes holding packaged food, bird excreta were on plastic wrap surrounding pallets of finished product and bird excreta were on the floor.
e. Rodent excreta pellets (REPs) were found within the North warehouse on February 17, 2011, including:
i. Sixty-six REPs were on the floor in the Northeast corner;
ii. Two REPs were on the floor in front of the walk-in cooler entrance; and
iii. Six REPs were on the floor behind the walk-in freezer along the East wall.
2. You failed to provide adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). Specifically, the roll-up door for the North and South warehouses were observed open to the exterior intermittently, greater than ten minutes at a time, while the doors were not in active use. On February 22, 2011, four live birds were observed directly below the roll-up door for the North warehouse when the door was open less than one foot in height.
3. You failed to maintain buildings, fixtures and other physical facilities in a sanitary condition to prevent food from being contaminated, and failed to clean and sanitize utensils in a manner that protects against contamination of food, food contact surfaces, or food-packaging materials, as required by 21 CFR 110.35(a). Specifically, our investigators observed:
a. Unpackaged food and spilled seeds on the floor of your warehouses in close proximity to stored food products, whereby such products may become contaminated; and
b. Residue accumulation on a product scoop in the repacking area in the South Warehouse.
4. You failed to provide sufficient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food, as required by 21 CFR 110.20(b)(1). Specifically, our investigators observed pallets of food products with no space in between the pallets, and pallets of food products placed directly against the wall throughout the North and South Warehouse, which does not allow adequate space for performing sanitary inspections, cleaning, or effectively monitoring for pest activity.
The above items are not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. You should take prompt action to correct these violations. Failure to do so may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.
In addition, FDA has determined that your facility is subject to the registration requirement in Section 415 of the Act [21 U.S.C. § 350d] and our implementing regulation at 21 CFR Part 1, Subpart H. During the inspection of your establishment located at 104 NW 49th Street, Auburn, Washington, you were advised of this requirement. The failure to register a facility as required is a prohibited act under Section 301(dd) of the Act [21 U.S.C. § 331(dd)]. Our records indicate that, to date, your facility has not been registered with FDA.
As a responsible official of a facility that manufactures/processes, packs or holds food for consumption in the United States, you are responsible for ensuring that your overall operations and the products you distribute are in compliance with the law.
We request that the owner, operator or agent in charge of your facility or an individual authorized by the owner, operator, or agent in charge, register the facility with FDA within 30 working days of the date of this letter. Registration may be accomplished on line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number. Alternatively, the owner, operator or agent in charge of your facility, or an individual authorized by the owner, operator, or agent in charge, may register the facility by mail or fax using FDA’s food facility registration form, Form 3537. This form is available for download at: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM071977.pdf or may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or (301) 575-0156, or writing to the agency at the following address:
U. S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by fax or mail and provide a facility’s registration number using the same method used to submit the registration to FDA.
You should respond in writing within 15 working days of receipt of this letter of the specific steps you have taken to correct the noted violations and to prevent recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Please send your reply to the Food and Drug Administration, Attention: Patricia A. Pinkerton, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have questions regarding any issues in this letter, please contact Patricia Pinkerton at 425-483-4926.
Sincerely,
/s/
Charles M. Breen
District Director
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