Donut Factory, LLC. 2/8/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
February 8, 2012
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 12-12
Ms. Vipharat Sithiphong, Owner
Donut Factory, LLC
6560 5th Ave S.
Seattle, Washington 98108-3432
Dear Ms. Sithiphong:
The Food and Drug Administration (FDA) conducted an inspection of your bakery located at 6560 5th Ave S., Seattle, Washington, on November 10 and 15-17, 2011. During the inspection, the FDA investigators 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.
We collected three samples from production areas while visiting your firm, Samples #653448, 653449, and 653450, consisting of rodent excreta pellets and rodent nesting material. Analyses of these samples were completed on November 22, 23, and 28, 2011, respectively. The samples were classified Class 3 for rodent excreta pellets (REPs) and rodent hairs. Additionally, live flies and snails were observed by the investigator.
Your significant violations are as follows:
1. Your firm failed to maintain effective measures to exclude pests from processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 1I0.35(c). Specifically, we observed:
a. One REP on the platform supporting plastic buckets of cube cut apple filling, located along the east wall of the back storage room.
b. Six REPs under the platforms supporting cases of palm oil shortening, located along the south wall of the back storage room.
c. Six REPs on the surface of a metal platform in the southwest corner of the back storage room.
d. Nine REPs under the metal platform supporting bags of raised donut mix, located along the west wall of the back storage room.
e. Thirty-six REPs on a wooden ledge near the northeast corner of the processing area, within six inches of the buckets of maple icing.
f. Ten REPs on the surface of a wooden shelf located in the southwest corner of the finished product storage room.
g. One REP suspended within insulation hanging from a hole in the ceiling in the southeast corner of the finished product storage room.
h. Three flies in the packaging area on the west side of the facility, near rolling racks full of finished donuts waiting to be packaged.
i. Four flies in the southwest portion of the processing area, near (b)(4) proofers and a sheeter. One fly was observed to land on the dough of multiple in-process raw donuts.
j. Rodent nesting material on a ledge within a three inch gap between the glass of the window in the north wall of the tools room and a makeshift fiber wall board, behind the tool chest.
k. REPs, too numerous to count, located on the ledge and within the nesting material described in (j).
l. Six REPs total under a tool chest on the north wall, along the west wall, and in front of a pallet of paper packaging materials along the south wall of the tools room.
m. Two live snails under a pallet of paper packaging materials, along the south wall of the tools room.
n. Seventy REPs total scattered across all the stair steps leading from the processing area to the break room.
o. REPs, too numerous to count, on the top surface of the ventilation hood suspended over the (b)(4) fryers in the processing area.
p. REPs, too numerous to count, located within and behind the debris pile in the break room.
q. Thirty eight REPs on the floor in the narrow walk space between the west perimeter wall of the facility and the finished product storage room, with packaged finished product being held within six inches of the walk space.
r. Eleven REPs on the top surface of an unused fryer, along the south perimeter wall, between the tools room and the sheeter in the processing area.
2. Your firm failed to provide adequate screening or other protection against pests [21 CFR 110.20(b)(7)]. Specifically, we found:
- The main west door was observed to be open various widths between approximately 1 inch and 1 foot on November 10, 2011, from 11:46 am to 4:38 pm.
- The loading door on the east wall was open various widths between approximately 2 feet and 6 feet on November 10, 2011, from 11:46 am to 4:38 pm.
- Three holes in the finished product storage room. Including one approximately 4 x 3 inch hole in the ceiling, one approximately 4 x 4 inch hole in the east wall near the ceiling, and another approximately 2 x 2 inch hole in the east wall near the ceiling.
3. Your firm failed to use sanitizing agents in a manner which is safe under conditions of use [21 CFR 110.35(d)(5)]. Specifically, we observed two racks that had been cleaned after the morning production and staged for use in the afternoon production that had icing and product residue remaining at one end.
During discussion of this with our investigator, you stated that employees do not use soap to wash the utensils, pots and racks so as not to alter the taste of the product. You stated that instead they rinse things with boiling water (poured into a sink) to remove residue, and then dip them in a light bleach solution. You do not use test strips to check the bleach content of the dip water. This method is not effective cleaning/sanitizing, since the boiling water immediately cools when pooled in a sink, and a period of time would be needed at boiling to achieve bacterial death; therefore it is critical that food residue and biofilms be physically removed (by cleaning with soap and hot water) prior to sanitizing.
4. Your firm failed to provide sufficient space for storage of materials as necessary for the maintenance of sanitary operations and the production of safe food [21 CFR 110.20(b)(1)]. We found seven instances where raw materials or supplies were stored directly against walls preventing adequate cleaning around those stacks/piles, and six of those with rodent excreta pellets under the storage platforms. Plus an eighth instance consisting of a pile of debris stored against the wall of the break room, with rodent excreta pellets within and behind the pile. Specifically:
a. Plastic buckets containing cube cut apple filling were stored directly against the east wall of the back storage room.
b. Cases of palm oil shortening were stored directly against the south wall of the back storage room.
c. Bags of raised donut mix were stored directly against the west wall of the back storage room.
d. A pallet of buckets of maple icing was stored directly against the wall in the northeast corner of the processing area.
e. A pallet of paper packaging materials was stored directly against the south wall in the tools room.
f. A tool chest was stored directly against the north wall of the tools room.
g. A pallet of paper packaging materials was stored directly against the west wall of the storage closet.
h. A debris pile was stored directly against the south wall of the break room. We recognize that during the inspection you moved supplies away from the walls of the back storage room.
This letter may not list all the violations at your facility. You are responsible for ensuring that your food facility operates in compliance with the Act and the Current Good Manufacturing Practice regulations (21 CFR Part 110) and food labeling regulations (21 CFR Part 101). 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: Heidi Marks, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Ms. Marks at (425) 483-4862 or via email at email@example.com.
Charles M. Breen