Inspections, Compliance, Enforcement, and Criminal Investigations
Homeneeds Samamish, Inc. 1/2/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
December 2, 2011
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 12-09
Samir P. Bhatt, President
21431 42nd Avenue SE
Bothell, Washington 98021
Dear Mr. Bhatt:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your food storage and repacking facility located at 14148 NE 190th Street, Suite 103, Woodinville, Washington, from June 20 through July 8, 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.
FDA’s laboratory tests of samples collected from your warehouse and various lots of food product confirmed the findings of rodent excreta pellets (REPs), rodent hair, and rodent urine stained and gnawed packaging throughout your facility.
Your significant violations are as follows:
1. You failed to take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises per 21 CFR 110.35(c). The investigators observed physical evidence of rodent activity throughout the facility including live and dead rodents, REPs, rodent gnaw holes, rodent urine stains, and live flies at various times on multiple days of the inspection. Specifically,
a. Live rodents:
i. At least two live rodents were observed inside packages of puffed rice cereal along the north wall adjacent to the employee restroom;
ii. One live rodent in a nest in the corner, southeast quadrant of the warehouse adjacent to the loading dock and the main entrance door (observed June 20, 21, 22, and 24, 2011). The rodent was located within four feet of the retail spice and soup mixes being stored on the central wall and within six feet of the repacking station where lentils and rice were being stored for future processing;
iii. One live rodent in the ceiling area running along pipes on the northeast quadrant north wall in the area above the pallet stacked with large bags of puffed rice and adjacent to the toilet facility (observed June 21, 2011);
iv. One live rodent in the ceiling area, northeast quadrant above the storage racks which line the central wall (observed June 21 and 24, 2011);
v. One live rodent among the floor pallets stored in front of the storage racks on the northeast quadrant east wall (observed June 20, 2011);
vi. One live rodent running across open floor space toward a pallet of food from the southeast quadrant central wall toward the south perimeter wall (observed June 27, 2011);
vii. One live rodent visible in the stack of puffed rice by the storage rack lining the northeast quadrant north wall adjacent to the employee restroom (observed June 21, 22, and 23, 2011). Two live rodents visible in this same area (observed June 24, 2011); and
viii. One live rodent was stuck on a glue board next to the bookshelf in the middle of the warehouse.
b. Dead rodents:
i. A dead and partially decomposed rodent carcass was observed in the northwest corner of the warehouse at the junction of the north and west perimeter walls and next to the west exit door (observed June 20, 2011);
ii. A dead rodent was observed in a snap trap on the top tier of the industrial shelving racks along the east wall of the northwest quadrant;
iii. A dead rodent was observed on a glue board on the floor in the southwest corner of the northeast quadrant; and
iv. A dead rodent was between pallets on the floor along the south wall of the northeast quadrant.
c. Rodent excreta pellets:
i. At least 185 REPs in a five foot long by five foot wide area on, and around products stored on the storage racks located in the northeast quadrant of the warehouse, south central wall;
ii. Eight REPs on top of cardboard cartons of red rose water on a floor pallet in front of the east perimeter wall storage racks;
iii. Thirty REPs under a pallet stored on the second tier of the north perimeter wall shelving next to the puffed rice stack, on glass jars of mango chutney being stored at floor level below, and on an adjacent floor pallet;
iv. Twenty-two REPs on top of a case of Masala Khari on the north perimeter wall shelving;
v. Twelve REPs on 2.5 Kg bags of dried tapioca balls on a floor pallet in front of the north perimeter wall shelving by the northwest corner of the warehouse;
vi. Eleven REPs within a two inch by two inch area on the floor behind a pallet stored on shelving on the north perimeter wall, midway between east and west walls;
vii. Sixty-four REPs in the corner on and around a pallet at the north and west perimeter wall junction by the west wall exit;
viii. Nineteen REPs on top of a case of (b)(4) Madhi Toor Dal unoily split pigeon peas on the west perimeter wall midway between the north and south walls;
ix. Twenty-two REPs on bags of rice and whole wheat flour on a floor pallet stored in front of the south perimeter wall shelving;
x. Thirty four REPs were on the top of a case of roasted vermicelli;
xi. Three REPs were within one inch of a rodent gnaw hole on a 20 lb. bag of Chappati flour atta;
xii. Three REPs were inside a reused cardboard box containing flour, co-mingled with green, yellow, and brown legume-type food bits;
xiii. Nineteen REPs on and next to a case of rice noodles stored open on the floor next to the west exit door. The REPs were co-mingled with bits of white paper-like material;
xiv. REPs were observed next to and on top of the retail pack boxes of Veg Kadhai, Pav Bhaji, and Veg Jalfrezi flavored spice mix;
xv. REPs were co-mingled with loose yellow, brown, and red lentils covering lentil cases on the second tier of the central wall on the north;
xvi. REPs comingled with lentils on the floor between the ready-to-eat Frooti juice drink tetra packs, Tendo 100% tender coconut water, and Kesar mango pulp cans being stored on pallets in the northeast quadrant, south central wall on the second tier of the storage rack; and
xvii. REPs were observed on top of, beside and underneath boxes of the retail spice and soup mix packages on the north central wall storage rack of the southeast quadrant.
d. Rodent urine stains:
i. Dhanajiru powder spice located on the second tier of industrial shelving racks along the south wall of the northeast quadrant exhibited at least nine rodent urine stains on the top of the corrugated cardboard case;
ii. At least 24 rodent urine stains were visible on the top face of 20 lb. paper packaging of (b)(4) Chappati flour on industrial shelving racks along the west wall of the southwest quadrant; and
iii. Green cardamom cases on a pallet in front of industrial shelving racks along the east wall of the northeast quadrant exhibited at least 39 rodent urine stains covering the surface of the corrugated case.
e. Rodent gnawing:
i. A case of mango flavored juice boxes on a pallet in front of the industrial shelving racks along the east wall of the northeast quadrant had a rodent gnaw hole approximately three inches in diameter and one box had a rodent gnaw hole with juice leaking from the hole;
ii. Roasted coriander seeds located on a floor pallet in front of the north perimeter wall storage racks in the northwest quadrant of the warehouse had rodent gnaw holes which penetrated the outside casing material, inside plastic package wrapping, and into the food;
iii. A case of roasted vermicelli on a pallet on the second tier of industrial shelving racks in the southwest corner of the northeast quadrant exhibited at least 13 rodent gnaw holes; the largest being five inches by three inches which penetrated the outer casing, and the inner individual plastic packaging to the exposed vermicelli noodles;
iv. Chappati flour atta, 20 lb. paper bags stacked on a pallet located by the north perimeter wall, exhibited numerous rodent gnaw holes as large as three inches in diameter which were gnawed through the outer paper bag and into the exposed flour inside;
v. Whole wheat atta exhibited rodent gnaw holes as large as three inches by four inches through the outer brown corrugated box and two holes as large as three inches in diameter through the plastic flour bag into the exposed flour;
vi. (b)(4) Chappati flour exhibited at least three rodent gnaw holes in the multi-layer paper sack packaging. The holes were as large as two inches in diameter and had urine stains within two inches of a rodent gnaw hole;
vii. Instant Pesarattu Mix on the industrial shelving racks along the north wall of the southeast quadrant exhibited a rodent gnaw hole three inches by four inches on the top of the cardboard box. A rodent gnaw hole one inch in diameter was penetrating the individual serving foil pouch to the exposed spices inside; and
viii. Veg Kadhai, Pav Bhaji, and Veg Jalfrezi flavored spice mix had rodent gnaw holes penetrating the cardboard boxes and some of the enclosed foil pouches.
f. Live flies were flying near the trash receptacle located in the northwest quadrant toward the center of the warehouse (observed June 20, 21 and 22, 2011).
2. You failed to provide adequate screening or other protection against pests as required by 21 CFR 110.20(b)(7). Specifically,
a. Along the west and south interior perimeter walls, the solid plywood walls extend only approximately 12 feet high. Above the plywood there is wire mesh with a two inch by two inch grid approximately four feet high. Above the wire mesh there is a gap of approximately 15 feet in height to the ceiling. The 15 foot gap extends the full length, approximately 70 feet, of the west perimeter wall and approximately 25 feet along the south wall. Two of the dock bay doors of the adjoining business were propped open during the inspection; and
b. The main entrance door located at the dock bay along the southeast quadrant, east wall exhibited a one inch gap along the width of the threshold and a one inch gap at the opening of the door that extends from the base up the side 24 inches.
3. You failed to have the plant constructed in such a manner as to allow walls to be adequately cleaned and kept clean and in good repair, and failed to provide adequate spacing in aisles or working spaces between equipment and walls as required by 21 CFR 110.20(b)(4). Storage racks, stored old equipment, floor pallets, and food items were stored in a manner that precludes cleaning and monitoring for pest activity and in a manner which creates a pest harborage condition. Specifically,
a. Along the east and south central walls of the northeast quadrant the yellow insulation appeared jagged as if portions were torn off. The insulation sheet was also separating from the wall;
b. On the south perimeter wall in the southeast quadrant behind the second tier of the storage rack was a section of insulation approximately four feet wide by four feet high that was detached from the wall and hanging over the remaining attached portion below. The detached portion appeared dingy brown in color instead of bright yellow like the surrounding attached insulation. At floor level in the same section of the storage rack, we observed 18 holes in the insulation, the largest measuring 24 inches high by five inches at the widest part;
c. The storage racks which line the perimeter walls on the south, west, north, east, and central walls are within three inches of the wall. Boxes stored at floor level under the storage racks are stored directly on the floor, with some of the boxes pushed back to the wall; and
d. Pallets stored on the floor in front of the north wall, south wall, southwest corner, east wall, and the corner by the east wall and central wall junction on the north side were stored directly adjacent to one another.
4. You failed to convey, store, and dispose of rubbish as to minimize the potential for the waste becoming an attractant and harborage or breeding place for pests, and protect against contamination of food, food contact surfaces, water supplies, and ground surfaces, as required by 21 CFR 110.37(f). Specifically, the trash receptacle located in the center of the warehouse was overflowing with garbage. On the top of the pile of garbage was observed two bags of flour with large rodent gnaw holes through the paper flour bag, and exposed flour falling out of the gnawed opening.
5. You failed to properly store finished food under conditions that will protect against physical contamination, as well as against deterioration of the food and container, as required by 21 CFR 110.93. Specifically, an open bulk-sized (approximately 40 lb.) flexible plastic bag with exposed yellow lentils was on the repacking table and an open plastic bag of Sona Masoori rice, shredded and open on the top, exposing the rice inside, was on the floor next to the repacking table. Old restaurant type equipment covered with a thick layer of dust and grime was stored within eight feet of the repacking table.
6. You failed to properly store equipment and remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures as required by 21 CFR 110.20(a)(1). Specifically,
a. On June 20, 21, 22, and 23, 2011, we observed on the outside of the building approximately 26 pallets, an overflowing trash receptacle, display materials, a banana peel, and paper and plastic debris lining the south face of the northeast exterior building wall and extending approximately 15 feet along the wall;
b. Old unused restaurant type equipment including deli display cases, videos, chairs, and a commercial convection oven was stored within eight feet of the repacking table in the southeast corner of the warehouse next to the loading dock bay in the southeast quadrant, stacked against the south wall. The stored old equipment extended six feet along the south wall and out into the dock area approximately five feet. The equipment was covered with a thick layer of dirt, dust, and grime, and was stored within six inches of foods stored on the storage racks that lined the south wall, 18 inches from food stored on floor pallets, and 18 inches from bags of flour and other food items stored on the dock platform; and
c. The food weighing scale on the repacking table was covered with old food, dirt, and grime.
7. You failed to maintain buildings, fixtures, or other physical facilities in a sanitary condition as required by 21 CFR 110.35(a). We observed the floors, storage shelves, employee break area, and office area to have an accumulation of dirt, refuse, REPs and food spills. Specifically,
a. The employee break area located in the northeast quadrant by the employee restroom had countertops and table tops with an old accumulation of caked on food spills and grime. Open food containers, soiled dishware, used empty paper beverage cups, debris, and an open trash receptacle were visible; and
b. On the bookshelf by the office area were used beverage cups, and a layer of dust and grime.
We acknowledge receipt on July 25, 2011, of your firm’s written response dated July 18, 2011, to the FDA-483, Inspectional Observations, issued to you at the close of the inspection. However, we were unable to properly evaluate your response since you did not provide any documentation of your implemented corrections, for instance, photographs of the improvements made to the building, or invoices of any new equipment or materials purchased. Your response did not address how you will remove the active rodent infestation in your facility and prevent re-infestation.
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. You should include in your response any documentation or other useful information that would assist us in evaluating your corrections. 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, Washington 98021-4421. If you have questions regarding any issues in this letter, please contact Patricia Pinkerton at 425-483-4926.
Charles M. Breen