| Public Health Service Food and Drug Administration |
Seattle District |
Department of Health and Human ServicesNovember 23, 2011
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 12-07
David R. Durrant, President
Big D Ranch, Inc.
7590 South Ten Mile Road
Meridian, Idaho 83642
WARNING LETTER
Dear Mr. Durrant:
On August 3-5, 2011, the U.S. Food and Drug Administration (FDA) conducted an inspection of your warehouse/packing facility located at 7590 South Ten Mile Road, Meridian, Idaho, and collected a filth sample from various buildings within your facility. Our investigators observed a number of objectionable conditions and practices, which cause the foods at your facility to be 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 they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You can find links to the Act and FDA's regulations through links on FDA's website at www.fda.gov.
In addition, FDA laboratory analyses of a filth sample found evidence of pest activity adjacent to raw agricultural product. Specifically, the filth sample confirmed the presence of mouse excreta pellets; bird excreta; hairs (mouse, dog/cat, and human); feathers (sparrow and unidentified); dead, adult insects (grain beetles, grain borers, spider beetles, flour beetles, and etc.); other whole dead insects and fragments (pseudoscorpions, flower fly, ham beetle, humpback fly, dermestid larva and cast skins, ants, and etc.); and live house mites.
Your significant violations were as follows:
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 evidenced by observations of live rodents and birds in the warehouses, and evidence of rodents/birds/insects throughout the warehouses which contain uncovered bulk beans and grains (or were impending receipt of such) as follows:
a. Building #(b)(4), - Observation in the NW comer of at least 40 rodent excreta pellets (REPs) on a wall ledge at floor/wall juncture, and a live rodent on the ledge at a hole in the wall. This building had been used to store oats, but was awaiting the next shipment, according to discussion with Mr. Richard Durrant.
b. Building (b)(4) - Observation of at least 36 REPs total along the west wall/floor juncture, on a wall ledge near SW corner, on the south wall ledge, and including one on the bulk pile of product. This building was currently storing feed barley.
c. Building (b)(4) - Observation of at least 8 REPs and bird excrement along the east wall ledge (just above bulk pile of beans), and no less than 5 live birds flying around and roosting above the beans. This building was currently storing pinto beans.
d. Building (b)(4) - Observation of at least 185 REPs, no less than 8 rodent burrow holes, and a live rodent, occurring throughout the building from north to south. This building had been used to store soft white wheat, and was due again to receive the next shipment a week after the inspection, according to discussion with Mr. Richard Durrant.
e. Building (b)(4) - Observation of a live rodent along the north wall on a pile of beans, at least 2 live birds, and no less than 2 bird nests actively in use. This building was currently storing pinto beans.
f. Building (b)(4) - Observation of no less than 100 scattered bird feathers, as well as a pile of bird feathers, all along the east and north walls. According to discussion with Mr. Richard Durrant, this building was in the process of being filled with incoming soft white wheat at the time of the inspection (both into the building and in a pile on the ground outside the building).
Rodent pellets, bird excreta, and insect/other filth were collected from the above referenced areas and laboratory analysis confirmed the pest activity.
We acknowledge that during close-out discussion with Mr. Richard Durrant, we observed that your the firm was in the process of cleaning out the REPs present in Buildings (b)(4) and (b)(4). In Building (b)(4) we observed your firm had cleaned the east wall ledge, and that your firm was in the process of cleaning out REPs in Building (b)(4) In Building (b)(4), we observed that your firm had removed bird nests. In Building (b)(4) we observed that your firm had removed bird feathers, installed streamers at the entryways of Buildings (b)(4) and purchased an owl decoy to mount in Building (b)(4) to discourage bird activity.
2. You failed to maintain buildings and facilities in repair sufficient to prevent food from becoming adulterated, as evidenced by holes and potential rodent/bird entryways throughout the warehouses as follows:
a. Building (b)(4) -Observation of a 1" hole in NW corner above wall ledge, with live mouse and REPs nearby.
b. Building (b)(4) - Observation of a number of 1/2'' holes to the outside and REPs nearby, on either side of the personnel-door on the west wall.
c. Building (b)(4) -Observation of a 6" gap at top of north overhead door when closed. Plus gaps of undetermined size in roof cap at north end of building. Birds were observed entering and exiting through these gaps.
d. Building (b)(4) - Observation of a crack in south wall, and a 2" hole through to the outside. with a live rodent attempting to exit through the hole.
e. Building (b)(4) -Observation of a number of holes from 1" to 3" along north wall, with live rodent nearby. Missing wall panel along south wall, creating gap approximately 6" x 12.'' Gap of approximately 3 "x 3" around an air duct penetrating the south wall, where one bird was observed to enter. At least 2 live birds seen in this building.
We acknowledge that during close-out discussion with Mr. Richard Durrant, we observed that the rodent entry hole in Building (b)(4) had been sealed, as well as the holes around the personnel-door in Building (b)(4) In Building (b)(4) we observed that your firm had closed off the roof and overheard door entry points that we had previously observed; however, there were still live birds present in the building. In Building (b)(4) we observed that your firm had sealed the rodent burrow holes, and was in the process of sealing cracks in floor, wall, and wall/floor junctures with concrete and steel wool. In Building (b)(4) we observed that the pile of pinto beans was moved away from the north wall, that your firm was in the process of repairing holes in that wall, and that your firm made repairs to the ceiling and other wall penetrations to prevent bird access.
The above violations are not meant to be an all-inclusive list of deficiencies in your facility. It is your responsibility to ensure that all of your products are in compliance with the Act and FDA regulations. You should take prompt action to ensure that your raw agricultural commodities are not prepared, packed or held under insanitary conditions which may cause them to become contaminated with filth or rendered injurious to health. Failure to promptly correct violations of the Act may result in regulatory action without further notice, such as seizure and/or injunction.
Please respond in writing within fifteen (15) days from your receipt of this letter. Your response should include each step that has been taken to completely correct the current violations and to prevent the recurrence of similar violations, the timeframe within which each correction will be completed, and any documentation necessary to show that correction has been achieved. For example, you should include records for ongoing sanitation control and monitoring of pests. If you cannot complete all corrections before you respond, please explain the reason for your delay and state when you will correct any remaining deviations.
Please send your written reply to the Food and Drug Administration, Attention: Heidi Marks, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Ms. Marks at heidi.marks@fda.hhs.gov or (425) 483-4863.
Sincerely,
/S/
Charles M. Breen
District Director
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