| Public Health Service Food and Drug Administration |
| Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 98021-4421 Telephone: 425-486-8788 FAX: 425-483-4996 |
Department of Health and Human Services
August 8, 2011
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In Reply Refer to Warning Letter SEA 11-20
Mr. Rex Wilhelm, President
The North West Company International, Inc.
550 W 64th Avenue
Anchorage, Alaska 99518
WARNING LETTER
Dear Mr. Wilhelm:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your food storage facility located at 2000 Taylor Way, Tacoma, Washington, on April 19, 20, 26, 27, and May 6,
2011. During the inspection, FDA investigators documented serious violations of FDA's Current Good Manufacturing Practice regulation 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, or whereby they may have been rendered injurious to health. You may find the Act and its implementing regulations through links on FDA's web page at www.fda.gov.
The following significant violations were observed during the inspection:
1. You failed to take effective measures to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically:
a. On April 19, 2011, a dead rodent was observed in a trap behind the pallet of 5 pound bags of sugar located in slot (b)(4), rack number 5.
b. On April 20, 2011, two twitching legs of a rodent were observed sticking out of a multi-catch trap located in pest control station number (b)(4).
c. On April 26, 2011, rodent gnawed flour bags were observed in the following locations:
i. One gnawed 10 pound flour bag on a pallet of (b)(4)-10 pound flour bags in slot (b)(4).
ii. One gnawed 5 pound flour bag on a pallet of (b)(4)-5 pound flour bags in slot (b)(4)
d. On April 27, 2011, rodent gnawed flour bags were observed in the following locations:
i. Four gnawed 5 pound flour bags on a pallet containing 5 pound flour bags in slot (b)(4).
ii. One gnawed 5 pound flour bag on a pallet of 5 pound flour bags in slot (b)(4)
iii. One gnawed 5 pound flour bag on a pallet of 5 pound flour bags in slot (b)(4)
iv. One gnawed 5 pound bag on a pallet of 5 pound flour bags in slot (b)(4).
v. One gnawed 5 pound bag on a pallet of 5 pound flour bags in slot (b)(4)
e. On April 19, 2011, seven rodent excreta pellets were observed on the plastic shrink wrap covering five different 4 packs of flour on a pallet containing (b)(4) 4 packs, a total of (b)(4)
10 pound bags, of flour with the lot number "BEST BEFORE 30 NOV 11".
f. On April 20, 2011, two rodent excreta pellets were observed on top of the brown paper that was wrapping 2-8 packs of bagged granulated sugar. The bags were on a pallet containing (b)(4) 8 packs, a total of (b)(4) 5 pound bags, of granulated white sugar with the lot number "71103".
g. On April 19, 2011, approximately 25 rodent excreta pellets were observed on the floor under racks 7 through 25. These racks were stocked with pallets of food.
h. On April 19, 2011, approximately 10 rodent excreta pellets were observed on the floor, underneath racks 5 and 6. The racks were stocked with pallets of a variety of food items.
i. On April 19, 2011, rodent excreta pellets were also observed in various areas throughout the warehouse:
i. Rodent excreta pellets (too numerous to count) were observed behind racks 26 and 60, along the south wall in an area of approximately 1 foot wide by 200 feet long.
ii. Three rodent excreta pellets were observed in the area adjacent to pest station (b)(4) and two rodent excreta pellets were observed in the area adjacent to pest station (b)(4). Both pest stations are located along the east wall of the warehouse.
iii. Sixty-two rodent excreta pellets were observed along the north wall, in an area approximately 2 feet wide by 360 feet long.
iv. Nine rodent excreta pellets were observed along the cooler wall, stretching east to west toward the freezer, in an area approximately 2 feet wide by 40 feet long;
v. Twenty rodent excreta pellets were observed in an area adjacent to pest station (b)(4)
vi. Ten rodent excreta pellets were observed in the southwest corner, in an area approximately 2 feet wide and 25 feet long, along with west wall.
2. You failed to provide, where necessary, adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). Specifically:
a. On April 19, 2011, the personnel entry/exit door in the southeast comer of the warehouse was observed to have an approximately 1/2 inch gap at the bottom of the door.
b. On April 19, 2011, the brush molding of the leveler of bay door 22 was observed to have slid downward, creating a space of approximately 2 inches long, 1 inch wide, and 1 inch high, between the leveler and the floor of the warehouse.
c. On April 20, 2011, an approximately 1 inch gap in length, width, and height was observed on the west side of the leveler of bay door 21.
d. On April 20, 2011, an approximately 1/2 inch gap was observed between the leveler of bay door 19 and the warehouse floor.
e. On April 20, 2011, the brush molding on the east side of leveler of bay door 13 is lower than the warehouse floor of the warehouse, creating an approximately 1 inch gap.
f. On April 20, 2011, an approximately 1 inch gap was observed around a gas pipe that enters the firm through the south wall.
Sample Results
During the inspection, we collected the following samples:
1. On April 19, 2011, sample #655028, which consisted of five subsamples of rodent excreta pellets, was collected from various areas of the floor around racks 5 and 6 and was analyzed by FDA's Pacific Regional Laboratory Northwest (PRLNW). Laboratory analysis confirmed the rodent excreta pellets to be rat excreta pellets.
2. On April 20, 2011, sample #655029, which consisted of 15 subsamples of rodent excreta pellets, was collected from various areas of the floors of the perimeter along the inner walls of the warehouse and was analyzed by FDA's PRLNW. Laboratory analysis confirmed the rodent excreta pellets to be rat excreta pellets. Analysis also found insects, specifically:
a. One dead adult grass fly (Chloropidae) was collected with the two rodent excreta pellets collected from the floor between slots (b)(4) and (b)(4);
b. One dead adult sewer fly (Psychodidae), one dead adult dark winged fungus gnat (Sciaridae), and one dead crane fly (Tipulidae) were collected with the one rodent excreta pellet collected from the floor adjacent to and east of rodent trap in pest station (b)(4).
3. On April 26, 2011, sample #655030, consisted of six subsamples of a cutting from a 5 pound bag of (b)(4) brand flour was collected and was analyzed by FDA's PRLNW. Laboratory analysis confirmed rodent gnawing on the bag.
4. On April 27, 2011, sample #655031, consisted of six subsamples of a cutting from a 10 pound bag of (b)(4) brand flour was collected and was analyzed by FDA's PRLNW. Laboratory analysis confirmed rodent gnawing on the bag.
We acknowledge your firm's voluntary corrective actions taken in response to the rodent activity noted in your facility. Also, we note your firm's voluntary corrections and commitment to correct the gaps around the doors. We note, on April 27, 2011, your firm, under the supervision of the FDA investigators, voluntarily destroyed bags of flour and one bag of dog food because the bags contained holes that appeared to be caused by rodent gnawing. We also acknowledge the written response to the FDA 483 from Randy Hinton, Director of Transportation and Logistics, dated June 1, 2011, which stated that your firm and the pest control company you have retained have increased surveillance of the facility for rodent activity and will be creating a written Integrated Pest Management Process to document findings. We will evaluate the effectiveness of your corrective actions during the next inspection of your facility.
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 the 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.
You should respond in writing within fifteen (15) working days of receipt of this letter describing 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 U.S. 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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