Inspections, Compliance, Enforcement, and Criminal Investigations
Quinault Indian Nation 9/7/10
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
September 7, 2010
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 10-30
Fawn Sharp, President
Quinault Indian Nation
P.O. Box 189
Taholah, Washington 98587
Dear Mrs. Sharp:
The Food and Drug Administration (FDA) conducted an inspection of your food commodity warehouse located at 166 First Avenue, Taholah, Washington, on January 14 and 15, 2010. The inspection was conducted to determine your compliance with FDA's Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). Our investigators documented serious deviations from the regulations that cause the products held in your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code 342(a)(4)) because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or may have been rendered injurious to health. You may find the Act and associated regulations through links in FDA's Internet home page at http://www.fda.gov.
Your significant violations were as follows:
1. No pests shall be allowed in any area of a food plant and 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 exclude rodents from your facility and to protect against the contamination of food on the premises by pests, as evidenced by observations of a live rodent in the warehouse and evidence of rodents throughout the warehouse, as follows:
a) A live black rodent was observed running from the southwest corner of the warehouse to the northwest corner. This rodent appeared to be relatively large, in an estimated 7" in length.
b) Rodent excreta pellets (REPs) were found throughout the food commodity warehouse. The REPs were found underneath all of the pallets containing food items, around the pallets' immediate surrounding areas and throughout the inside perimeter, as follows:
• At least 300 REPs and nesting material were observed in the corner adjacent to the pedestrian door on the south wall.
• At least 125 REPs and fluorescent urine stains were observed underneath a forklift in the northwest corner.
• 87 REPS were observed underneath a wooden pallet holding one opened case of boxed corn flakes in the middle of the warehouse.
• At least 75 REPs were observed on and around a wooden pallet stored along the west wall in the northwest corner.
• At least 50 REPs were observed on the floor between the wall and door of the walk-in cooler.
• Twelve REPs were observed underneath a wooden pallet holding 20 cases of canned mix fruit and apricot halves along the north wall;
• Nine REPs were observed underneath a wooden pallet holding cases of canned orange juice on the north side of the warehouse.
• Eight REPs were observed underneath a wooden pallet holding cases of canned food product and three REPs were observed underneath a second wooden pallet holding cases of canned food product along the north wall of the warehouse.
• Ten REPs were observed surrounding black garbage bags and debris in the southwest corner of the warehouse).
• Seven REPs were observed surrounding a (b)(4) brand rodent trap adjacent to wooden pallets on the floor.
2. You must store finished food under conditions that will protect food against physical, chemical, and microbial contamination, as well as against deterioration of the food and the container, to comply with 21 CFR 110.93. However, you failed to store finished food under conditions that will protect food against physical, chemical, and microbial contamination, as evidenced by:
• Water observed leaking from the water stained ceiling in close proximity to the packaged food products.
• Pooled water observed on the warehouse floor, approximately one foot from stored packaged food.
• Cardboard cases of finished food products being stored directly on the warehouse floor.
3. Plant building and structures must be maintained in a sanitary condition and kept in repair sufficient to prevent food from being adulterated within the meaning of the Act, in accordance with 21 CFR 110.35(a). However, your firm failed to maintain the building and structure in a sanitary condition and in sufficient repair, as evidenced by:
• Insulation falling from the ceiling panels and gaps along the ceiling along the north wall.
• A gap between the wall and the ceiling, and insulation falling in the corner west of the pedestrian door.
• Gaps between the east wall and the adjoining ceiling, and above the south exit door and ceiling area, in the southeast corner.
• False ceiling tile pulled away from the ceiling wood support beams along the east wall.
• False ceiling tile detached from the wood support along the south wall.
• False ceiling tiles detached from the wood support beams, and ceiling tiles exhibiting water stains, in the center of the warehouse.
• Stained false ceiling panels detached from the wood support section in the southwest corner.
• False ceiling tiles exhibiting staining and/or detached from the upper wood support along the west wall.
4. You must properly store equipment, remove litter and waste, and cut weeds or grass within the immediate vicinity of the plant buildings or structures that may constitute an attractant breeding place, or harborage for pests, in order to comply with 21 CFR 110.20(a)(1). However, your firm failed to properly store equipment, remove litter and waste, and cut weeds or grass within the immediate vicinity of the plant buildings or structures that may constitute an attractant breeding place, or harborage for pests, as evidenced by:
• Overgrowth of shrubs, grass, and weeds along the commodity warehouse east wall.
• Overgrowth of shrubs, grass, weeds, the presence of wooden beams, other miscellaneous debris, and a truck trailer behind the commodity warehouse along the west wall.
• Empty cardboard boxes and wooden pallets stored near a freezer by the west wall.
• Empty cardboard boxes, plastic bags, and plastic "milk" type crates stored on the floor along the southwest wall.
This letter may not list all the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and the Current Good Manufacturing Practice regulations (21 CFR Part 110). You should take prompt action to correct these violations. Failure to promptly correct these deviations may result in regulatory action, including 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 violations and prevent their recurrence. You should include in your response any documentation that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your written reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Mr. Donovan at (425) 483-4906.
Charles M. Breen