Inspections, Compliance, Enforcement, and Criminal Investigations
West Coast Pita and Food, Inc. 04-Jan-07
Department of Health and Human Services
Public Health Service
January 4, 2007
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 07-04
Ali K. AI-Shaibani, President
West Coast Pita and Food, Inc.
127204 th Avenue West, Suite F-380
Everett, Washington 98204
Dear Mr. AI-Shaibani:
The Food and Drug Administration (FDA) conducted an inspection of your food storage facility, located at 20241 84th Avenue South, Kent, Washington, on September 27, 28, and 29, and October 3, 2006. The inspection revealed insanitary conditions and serious violations of Title 21 of the Code of Federal Regulations (CFR) Part 110-Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (GMP). These conditions cause the food products produced in your facility to be adulterated within the meaning of Section 402(a)(4) [21 U.S.C. 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act), in that they have been held under insanitary conditions whereby they may have become contaminated with filth. You can find the Act through links in FDA's homepage at www.fda.gov.
At the conclusion of the inspection, you were issued a Form FDA-483 (copy enclosed), which delineated a number of significant deficiencies:
1. Effective measures must be taken to protect against the contamination of food on the premises by pests, to comply with 21 CFR 110.35(c). However, you failed to take effective measures to protect against the contamination of food on the premises. Specifically, three lots of rice, consisting of [redacted] lbs, and one lot of couscous, consisting of [redacted] lbs, were observed to be contaminated by rodents, as evidenced by the following:
a.) A pallet of "SHABNAM" rice was observed to have an average of 15 rodent excreta pellets (REPs) on the surface of each of 55 bags in the top three layers of the pallet (an estimate of 825 REPs). Six bags were observed to have a minimum of two rodent urine stains per bag that fluoresced under black light on the first layer of the pallet. One bag was observed to have a rodent gnawed hole (exposing the product) on the first layer of the pallet.
b.) A pallet of "NASIM" rice was observed to have an average of five REPs on the surface of each of 15 bags in the top four layers (an estimate of 75 REPs) of the pallet. Five bags were observed to have a minimum of one rodent urine stain per bag that fluoresced under black light on the fourth layer of the pallet.
c.) Another lot of "NASIM" rice was observed to have a minimum of two rodent gnawed holes on each bag of product.
d.) A pallet of "ROYAL" couscous was observed to have an average of 23 REPs on the surface of each of 27 bags in the top four layers (an estimate of 621 REPs) of the pallet. Five bags were observed to have a minimum of one rodent urine stain per bag that fluoresced under black light on the fourth layer of the pallet. One bag was observed to have rodent gnawed holes (exposing the product) on each of the top four layers. Rodent gnawed holes were also observed on ten bags in the bottom five layers that make up the perimeter of the pallet.
2. Pests must not be allowed in any area of a food plant, to comply with 21 CFR 110.35(c). However, you did not exclude rodents and birds from your food storage facility, as evidenced by following:
a.) A dead rodent (rat) was observed hanging from mesh wire that is mounted above the closet located in the northeast corner of the warehouse, adjacent to the office.
b.) Rodent droppings were noted throughout the warehouse. These were observed on the inside cases of food products, on tops of cases of food products, on pallets holding food products, and on floors and under pallets adjacent to stored food. For example:
• 45 rodent droppings were observed on the floor around the perimeter, on top of pallets with product (cheese wrapped in plastic inside an open paper box), and on top lids of five gallon plastic tubs containing Salonika peppers, located inside the cooler.
• An estimated 250 rodent dropping were observed on the floor, underneath a pallet containing mixed products (broken bags of milled wheat and corn, canned garbanzo beans, canned olives), located at the east end of the second pallet rack from the north wall, adjacent to the display shelf.
• An estimated 100 rodent droppings were observed on top of a pallet with product cases (olive oil in rigid plastic jars), located on the east end of the first pallet rack from the south wall, adjacent to the southeast door.
c.) A live bird was observed flying and roosting inside the warehouse, located in the center of the top shelf of the second pallet rack from the south wall.
3. Buildings, fixtures, and facilities must be maintained in sanitary condition to prevent food from becoming adulterated within the meaning of the Act, to comply with 21 CFR 110.35(a). However, you did not maintain your facility in a sanitary condition, as evidenced by:
a.) The presence of rodent excreta inside cases of food products, on tops of cases of food products and on pallets holding food products, as delineated in item 2, above.
b.) Opened, exposed, damaged, leaking, and spilled containers of product were observed in multiple locations throughout the warehouse, storage cooler, and walk-in freezer, providing an attractant for pests. For example we observed:
• Ten open bags of couscous with product spilled on the floor were observed at the east end of the first pallet rack from the south wall.
• One open case of whole dates on a pallet and one case of whole dates on the floor of the cooler.
• One open package of frozen chicken rolls spilled inside its own shipping carton in the freezer.
• Three cases of juice in glass bottles, located between the two bay doors that were leaking.
c.) Two bags containing moldy pita bread and one wood pallet (holding five gallon tubs of peppers) with mold growth covering its surface stored inside the cooler.
4. Facilities must provide adequate screening or other protection against pests, to comply with 21 CFR 110.20(b)(7). However, you did not provide adequate screening or other protection against pests as evidenced by the presence of rodents and a bird in your facility. Specifically, the loading bay doors and the pedestrian door to the outside were observed to be open during the first half of the first day of the inspection, which allowed the bird to enter the warehouse and also provided potential rodent entry. The doors did not have screens mounted on them to prevent pests from entering.
We acknowledge your written response, dated October 3, 2006, outlining your corrective intent regarding the observations on the Form FDA 483, Inspectional Observations, left with you that same day. We also acknowledge and appreciate your efforts to clean the warehouse following our inspection and your actions in destroying the lots of products described in item 1, above, once you were notified of their suspected contamination by our investigator.
The above violations are not meant to be an all-inclusive list of deficiencies in your facility. It is your responsibility to assure that all of your products are in compliance with applicable laws and regulations. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. 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 reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Michael J. Donovan, Compliance Officer, at (425) 483-4906.
Charles M. Breen
Form FDA 483
cc: WSDA with disclosure statement