Big Daddy's Creamery LLC dba Theno's Dairy

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 98021-4421 Telephone: 425-486-8788 FAX: 425-483-4996

July 21, 2010

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 10-26

Douglas J. Bloor, Owner
Big Daddy's Creamery, LLC
dba Theno's Dairy
12348 Woodinville-Redmond Road
Redmond, Washington 98052-2041

WARNING LETTER

Dear Mr. Bloor:

The Food and Drug Administration (FDA) conducted an inspection of your ice cream manufacturing facility located at 12348 Woodinville-Redmond Road, Redmond Washington, on April 20, 21, and 27, 2010. During the inspection, the FDA investigator documented serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 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 the FDA regulations through links in FDA's homepage at www.fda.gov.

Your significant violations are as follows:

1. You failed to take effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. 21 CFR 110.35(c). Specifically, the investigator observed:

Rodents:

a. One dead rodent on the floor along the south wall of the breezeway, near the ramp leading to the hallway connected to the Pasteurizing Room.
b. One dead mouse in the entryway leading to the restroom, where the compressor for the Ice Cream Freezing Room is located.
c. At least 27 rodent excreta pellets (REPs) on the floor adjacent to a bait trap in the hallway near the entrance to the Pasteurization Room.
d. At least 96 apparent REPs in the storage areas surrounding the upper walk-in freezer which holds finished three gallon containers of ice cream.

Insects:

a. Eight dead adult psocids (e.g., booklice) and one dead adult fly on the outside surface of the light fixture which was located directly above an opened vat containing pasteurized ice cream mix in the Pasteurization Room.
b. At least 150 dead insects on a strip of tape suspended from a metal hanger located behind the mixer along the south wall of the Pasteurization Room.
c. Four live moths on the West wall approximately six feet behind the batch freezer within the Ice Cream Freezing Room during production on April 21, 2010.
d. At least 50 live pavement ants on the floor of the container storage area within the Ice Cream Freezing Room during production on April 20, 2010.
e. Live and dead insects and one live spider on the windowsills along the west walls in the Pasteurizing Room and Ice Cream Freezing Room.
f. One live insect on the East wall above the vat in the Pasteurization Room.

Birds:

a. One bird feather in the hallway between the boiler and entrance to the breezeway approximately ten feet from the entrance to the Pasteurizing Room.
b. Apparent bird excreta droppings on the ramp within the breezeway which leads to the hallway connected to the Pasteurizing Room.
c. Apparent bird excreta and bird feathers within the storage area of the breezeway.

We acknowledge receipt of your written response to the FDA-483, Inspectional Observations, issued to you at the close of the inspection. Your response to this observation appears partially adequate, in that you state you have removed the rodents and REPs and cleaned up the insect and bird activity in the facility. However, your response is inadequate in that you have not provided documentation of the steps you have taken or are taking to correct the violations. For example, you have not provided pictures of the cleaned areas that were noted to have been contaminated with rodents, birds and insects, or proof of payment to service persons to clean up the contamination and eliminate the pests. Your response indicates that you enacted measures with your pest control contractor but provides no evidence of additional contracts or other measures to improve pest control in and around the plant. Further, you have failed to follow through with corrective actions for these deficiencies that you promised during past inspections and in a telephone meeting held with our Compliance Officer on November 10, 2009.

2. You failed to provide adequate screening or protection against pests as evidenced by rodent, insect and bird activity in your facility. 21 CFR 110.20(b)(7). Specifically, the investigator observed:

a. The unscreened sliding door from the breezeway to the loading dock open to the outside throughout the inspection on April 20 and 21, 2010.
b. A one inch gap from the floor to the bottom of the plastic curtains in the doorway between the breezeway and hallway connected to the Pasteurizing Room.
c. Gaps, approximately two inches in size, between the strips of the plastic curtains in the doorway between the hallway and Pasteurizing Room.
d. One hole surrounding a gutter that entered through the South wall of the breezeway and allowed water into the breezeway.
e. Gaps along the West wall and roof of the breezeway that allowed rain water into the breezeway.

All of these openings may provide potential pest entry into your facility.

With respect to items (a)-(c), your response to the FDA 483 appears partially adequate in that you state you will rework these doorways with plastic curtains. However, your response is inadequate in that you have not provided any
documentation to show the purchase or installation of the plastic curtains. Your response is also inadequate regarding items (d)-(e) in that you plan to implement corrective actions "hopefully by the end of summer." This is an unacceptable timeframe as these openings may continue to provide pest entry into your facility. Further, you have made commitments to correct similar deficiencies during past inspections and in a telephone meeting held with our Compliance Officer on November 10, 2009, but you have failed to follow through with the appropriate corrective action.

3. The plumbing in your facility must be adequately installed and maintained to avoid constituting a source of contamination to food, water supplies, equipment, or utensils. 21 CFR 110.37(b)(3). However, while a production employee was washing his hands, the investigator observed the waste water exiting the hand washing sink, directly onto the floor, past the production employee's shoes and into a drain located in the center of the Pasteurization Room, approximately eight feet away from the sink. Additionally, the investigator observed waste water from the three compartment sink flooding a ten foot area surrounding a floor drain along the South wall of the Ice Cream Freezing Room. This waste water had been used to wash and sanitize plastic containers.

Your written response to this observation is inadequate. This is a serious violation that requires immediate corrective action. Waiting until the "winter of 2011" to "attempt" corrective action is not acceptable. Furthermore, you indicate that you will research a foot bath system as an interim solution; however, this is not an adequate correction for this observation.

4. You failed to ensure that equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food are constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination. 21 CFR 110.80(b)(7). Specifically, the investigator observed:

a. A stack of white three gallon plastic containers used to hold finished ice cream inverted and stored directly on the floor along the East wall in the Pasteurizing Room and Ice Cream Freezing Room.
b. Three white plastic lids used to cover the three gallon containers which hold finished ice cream stored within the hand washing sink in the Pasteurization Room.
c. Cracked, corroded, and unsmooth welding at the corners of the vat where pasteurized ice cream mix is filled and stored, and corroded metal arms that are used to prop open the lid of the vat.

Your written response to this observation is inadequate in that you have not provided documentation to confirm the steps you have taken or are taking to correct the deficiencies. For example, you did not provide photographs or other documentation that the containers are properly stored or documentation of payment to service personnel to weld the vat. Further, you have made commitments to correct the violations noted in this observation during past inspections, but you have failed to follow through with the appropriate corrective action.

5. Plants and facilities must be constructed in such a manner as to allow floors to be adequately cleaned and kept clean and in good repair. 21 CFR 110.20(b)(4). However, our investigator observed that the floor in the Pasteurization Room was cracked, which exposed the rough porous composite, particularly surrounding the floor drain in the Pasteurization Room.

Your written response to this observation is inadequate. Waiting until the "winter of 2011" is not an acceptable timeframe to resurface the floors. This is a serious violation that requires immediate corrective action. Further, you have made commitments to correct the violations noted in this observation during past inspections and in a telephone meeting held with our Compliance Officer on November 10, 2009, but you have failed to follow through with appropriate corrective action.

6. You failed to properly store equipment within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harborage for pests. 21 CFR 110.20(a)(1). Specifically, the investigator observed:

a. Roller conveyors, plastic crates, a fan, and litter, such as glass containers, tires, metal milk cans and paint cans stored inside the facility in the breezeway and the storage areas between the lower and upper freezers.
b. A freezer, plastic crates and wooden pallets stored outside of the facility in the loading dock area.
c. Litter, such as metal and plastic piping, stored outside of the facility in the alley between the restroom and Ice Cream Freezing Room pedestrian door.

Your response to this observation generally appears adequate except that you did not provide documentation such as photographs of the areas you have cleaned up or receipts or other documentation to demonstrate the disposal of the removed items. Further, you have made commitments to correct the deficiencies noted in this observation during past inspections and in a telephone meeting held with our Compliance Officer on November 10,2009, but you have failed to follow through with the appropriate corrective action.

7. You failed to provide your employees with adequate toilet facilities. 21 CFR 110.37(d). Our investigator observed yellow stains on the wall, brown grime on the floor, sink and toilet, and paper on the floor and top of the refuse receptacle.

Your response to this observation generally appears adequate except that you did not provide documentation such as photographs to demonstrate the bathroom has been cleaned and painted. Further, you have made commitments during the March 2007 inspection to correct the deficiencies noted in this observation, but you have failed to follow through with the appropriate corrective and preventive actions.

8. You failed to maintain buildings, fixtures, and other physical facilities in a sanitary condition and keep them in repair sufficient to prevent food from becoming adulterated. 21 CFR 110.35(a) and 110.20(b)(4). Our investigator observed the following:

a. Rain water falling from the gutter within the breezeway onto plastic curtains in the doorway between the breezeway and hallway as well as onto the ramp within the breezeway, which production employees pass through while transporting finished product.
b. Accumulated water pooled on the floor of the walk-in cooler located in the Pasteurizing Room.
c. Spilled ice-cream on the floors and shelves of the upper freezer used to store finished ice cream.
d. Ice build-up on the floors and shelves of the upper freezer used to store finished ice cream.
e. Spilled ingredients used to manufacture ice cream underneath storage shelves in the dry ingredient storage room and in the walk-in cooler of the Ice Cream Freezing Room.
f. Rusted storage shelves in the walk-in cooler of the Ice Cream Freezing Room which hold raw ingredients.

Your response to items (b), (e), and (f) generally appear adequate. However, your response to items (a), (c) and (d) is inadequate in that the timeframes you provided, "hopefully end of summer" and "Winter 2010," are not acceptable. These are serious violations that require immediate corrective action. Further, you have made commitments to correct the violations noted in this observation during past inspections and in a telephone meeting held with our Compliance Officer on November 10, 2009, but you have failed to follow through with appropriate corrective action.

This letter may not list all the violations at your facility. You are responsible for ensuring that your facility and your products are in compliance with the Act and the Current Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Failure to implement lasting corrective action of these violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.

We request that you notify this office in writing, within 15 working days from your receipt of this letter, of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation such as certification of actions performed by a licensed exterminator, other actions performed to control unauthorized entrance of pests, plans on how you plan to protect food products from possible contamination, and/or any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will 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

cc: WSDA with disclosure statement

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