| Public Health Service Food and Drug Administration |
Seattle District |
Department of Health and Human ServicesSeptember 9, 2011
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 11-22
Jeffery W. Babcock, Owner
Zoka Coffee Company, LLC
1220 W. Nickerson Street
Seattle, Washington 98119-1125
WARNING LETTER
The U.S. Food and Drug Administration (FDA) conducted an inspection of your coffee roasting facility located at 1220 W. Nickerson Street, Seattle, Washington, on April 14-15, 18, and 20-22, 2011. During the inspection, FDA investigators documented serious violations of FDA's Current Good Manufacturing Practice (CGMP) regulation for foods (21 CFR Part 110). These violations 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 prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You can find the Act and FDA's regulations through links on FDA's homepage at www.fda.gov.
The following significant violations were observed during the inspection of your facility:
1. You failed to take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, our investigators observed the following evidence of rodents and insects:
Storage Area:
Two lots of whole green coffee beans contained evidence of rodent and insect infestation. With respect to lot 002/5405/0502, which consisted of (b)(4) palletized 132 lb. burlap bags, 1 partial burlap bag containing 9.1 lbs., and 1 partial burlap bag containing 48.8 lbs, we observed:
• 79 rodent excreta pellets (REPs) were observed directly on the surface of burlap bags of green coffee beans throughout a pallet of (b)(4) 132 lb. bags. Rodent nesting material was observed on the bottom layer on a pallet of stacked bags; and
• 17 REPs and one apparent insect larvae with insect webbing were observed on the surface of burlap bags of green coffee beans on a stacked pallet of (b)(4) 132lb bags.
With respect to lot 002/1961/0777, which consisted of (b)(4) 132 lb. burlap bags, 1 partial burlap bag containing 70 lbs., and 1 partial burlap bag containing 11.4 lbs, we observed:
• 55 REPs were observed on the surface of burlap bags of green coffee beans throughout a pallet of (b)(4) 132lb burlap bags. A gnaw hole approximately 1/2 inch in diameter was found on one burlap bag. Three insect larvae with webbing and two live insects were found on the outside of the burlap bags;
• 10 REPs were observed on the surface of burlap bags of green coffee beans on a pallet of (b)(4) 132 lb. burlap bags. 12 REPs were found on the cardboard slip underneath the pallet; and
• 27 REPs were observed inside the shrink-wrap surrounding (b)(4) pallets, each containing (b)(4) 132 lb. burlap bags of green coffee.
Production Room:
• At least 200 REPs and a fluorescent stain were observed on and around the bottom shelf of a shelving unit stored in the southwest area;
• At least 115 REPs were observed along the floor/wall junction and among stored boxes in the southwest area;
• At least 144 REPs were observed on the floor surrounding and throughout two stacks of empty pallets stored in the southwest corner;
• 68 REPs were observed on the floor along the south wall in the southeast corner;
• 52 REPs were observed on the floor between plastic bins containing roasted coffee and the west wall;
• A hole behind a shelving unit in the southeast corner containing at least 3 REPs;
• An approximately 20 inch wide gap approximately 4 inches above the floor/wall junction between the cement ledge and wood wall along the west wall, containing 55 REPs;
• At least 90 REPs were observed against the south wall between the (b)(4) and (b)(4) rows of pallets containing green coffee beans in burlap bags;
• At least 300 REPs and fluorescent stains were observed on the floor along the west wall south of the main stairwell; and
• 33 REPs were observed against the south wall between the two western most rows of pallets containing green coffee beans in burlap bags.
Training Room:
• 22 REPs were observed in the production room along the front floor/wall junction;
• At least 100 REPs were observed at the floor/wall juncture behind storage racks and Styrofoam packaging material along the south wall;
• 55 REPs were inside a cardboard box with loose tea; and
• Three holes were observed along the north wall, 1 inch wide containing 4 REPs, 2 1/2 inches wide, and 6 inches in width containing 6 REPs.
Break Room:
• At least 40 REPs were observed at the floor/wall junction along the north wall;
• At least 120 REPs were observed on the surface of two tables along the east wall, and at least 175 REPs were observed beneath the same two tables; and
• Two holes, were observed, one hole, 2 1/4 inches wide, in the northeast corner, and one hole, 2 1/2 inches wide, along the south wall, containing at least 4 REPs.
Tea Repackaging Area:
• REPs were observed on the floor and on shelving units.
One live rodent, approximately 4 inches long, was observed in an open doorway leading from the main stairwell toward the tea re-packing area.
We acknowledge receipt of your May 9, 2011, response to the FDA-483", which was issued to you at the close of the inspection. While your response indicates that you have taken some corrective steps to address the rodent infestation in your facility, your response is nonetheless inadequate. Your response did not specifically address what, if any, corrective actions you have taken to clean the rodent excreta pellets that were observed in your facility and to sanitize the areas where the pellets were found. Nor did you provide documentation of other corrective actions.
We also acknowledge that on April 18, 2011, FDA witnessed you voluntarily destroy two 132-lb burlap bags of green coffee beans, lot 002/5405/0502, which were contaminated with rodent filth.
2. You failed to provide adequate screening or otherwise protect against pests, as required by 21 CFR 110.20(b)(7). Specifically, a gap 3/4 inches high was observed under the main door in the northeast corner leading directly outside.
3. Employees did not wash hands thoroughly in an adequate hand-washing facility after the hands may have become soiled or contaminated, as required by 21 CFR 110.10(b)(3).
Specifically, our investigators observed the following during the inspection:
• On April 20, 2011, an employee was observed sneezing directly into his bare hand, then touching the inside of a plastic bag in which tea was being emptied into without
previously washing their hands.
In your response dated May 9, 2011, you stated that you have trained employees in hygiene. However, your response is inadequate because you failed to specify what training employees received, thereby making it impossible for FDA to evaluate whether you have corrected this violation.
4. You failed to handle and maintain containers, equipment, and utensils used to convey, hold, or store raw materials, work-in-process, and food in a manner that protects against contamination, as required by 21 CFR 110.80(b)(7). Specifically, our investigators observed the following during the inspection:
• On April 14, 2011, large plastic containers holding roasted coffee beans were being stored directly on the floor within approximately five inches from REPs. Some of these containers were also stored on top of one another. A scoop used to transfer coffee was stored on top of a lid of one of these containers.
• On April 15, 2011, brown residue surrounding tape was observed on the food contact surface of a metal scoop used to scoop roasted coffee beans into finished product packaging. The scoop was observed stored on the lid of plastic containers holding roasted coffee beans.
• On April 15, 2011, a pitted and scratched metal tube used to convey roasted coffee beans from plastic bins to the weigh-and-fill apparatus, was stored on a metal rail near the base of the machine in which a brown residue was found. The metal tube was then observed in roasted coffee beans.
• On April 20, 2011, worn blue and brown plastic tape was observed on the handle of a metal scoop used by an employee while repacking tea.
In your response dated May 9, 2011, you promised corrective action by July 1, 2011. However, your response is inadequate because you did not provide any follow up to assist us in evaluating your corrections.
5. You failed to maintain physical facilities in repair in a sanitary condition and keep them in repair sufficient to prevent food from becoming adulterated, as required by 21 CFR 110.35(a). Specifically, on April 14, 2011, we observed liquid dripping from two points of the ceiling and running down the side of the roaster exhaust system down to the floor of the production room. Green coffee beans in burlap bags were stored on a pallet near where the liquid was collecting.
In your response dated May 9, 2011, you stated that you will complete the work to repair the roof leaks by June 1, 2011. However, your response is inadequate because you failed to provide any follow-up to assist us in evaluating your corrections.
6. You failed to provide safety-type light bulbs suspended over exposed food or to otherwise protect against food contamination in case of glass breakage, as required by 21 CFR 110.20(b)(5). Specifically, our investigators observed four unshielded fluorescent bulbs directly above the tea repackaging area where an employee was working with bulk tea which would be ready for distribution with no further processing.
In your response dated May 9, 2011, you promised correction by June 1, 2011. However your response is inadequate because you failed to provide any follow-up response that would assist us in evaluating your corrections.
The above violations are not intended to be an all-inclusive list of all the violations at your facility. You are responsible for ensuring that all of your products are in compliance with the Act and FDA's implementing regulations, including Current Good Manufacturing Practice regulations (21 CFR Part 110).
You should take prompt action to correct the violations cited in this letter. Failure to correct these violations may result in regulatory action without further notice, such as seizure or injunction.
You should notify this office in writing within 15 working days from receipt of this letter. Your response should include each step taken or that will be taken to correct the violations and prevent recurrence. You should include in your response any documentation or other useful information 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 reply to the Food and Drug Administration, Attention: Brenda L. Reihing, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Brenda Reihing at (425) 483-4899.
Sincerely,
/S/
Charles M. Breen
District Director
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