Inspections, Compliance, Enforcement, and Criminal Investigations
Golden Crown Bakery, Inc. dba Panzanella Bread Company 3/6/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Avenue SE, Suite 210
Bothell, WA 98021
March 6, 2014
In reply refer to Warning Letter SEA 14-05
Jurgen F. Bettag, Owner
Golden Crown Bakery, Inc.
dba Panzanella Bread Co.
12310 Highway 99, Unit 116
Everett, Washington 98204-8518
Dear Mr. Bettag:
The Food and Drug Administration (FDA) conducted an inspection of your food manufacturing firm located at 12310 Highway 99, Units 115-117, Everett, Washington, on January 27-31 and February 4, 2014. During the inspection, an FDA investigator documented serious violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food, 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 on FDA's homepage at www.fda.gov.
In addition, sample 788645, a filth exhibit, collected during the inspection, was analyzed by FDA’s Pacific Regional Laboratory Northwest. Laboratory analyses of the sample confirmed the presence of rodent excreta pellets (REPs) which had been collected from several areas of the first floor production room, and Tribolium confusum (confused flour beetles) was found in the production mezzanine level where raisins, glace lemon peel, and dried ingredients were being stored.
Your significant violations were as follows:
1. Your firm 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, as required by 21 CFR 110.35(c). Specifically, our investigator discovered evidence of rodent activity, at least 550 REPs in the western half of the facility and live and dead insect activity near foods stored in your food processing facility. Our investigator observed freshly baked bread products, in-process dough, and food items used in bread production exposed to rodent and insect activity in the production room, production mezzanine, and maintenance mezzanine as evidenced by the following:
a. In the production room:
i. Three REPs were observed in an empty pan which was stored on the bottom shelf of a bread rack in the oven staging area. Pans of uncovered bread dough were also being stored on the same rack on the third shelf from the bottom.
ii. Eight REPs were observed on floor underneath a table located by the (b)(4) dough divider. These REPs were on the floor between and near plastic containers of flour. Rustic roll dough was being formed into rounds on the table surface.
iii. Four REPs were observed inside a baking pan stored on a rack located on the second shelf from the bottom. Uncovered (b)(4) dough was being stored in several pans on the top shelves of the same rack. This rack was located by the west perimeter wall.
iv. One REP was observed on the second and third shelves from the bottom of a rack located by the west perimeter wall. This rack had been moved to this area after it was used to store uncovered Sourdough bread loaves, French baguette, and Cheese baguette prior to baking. Our investigator observed that once the bread was placed in the oven, the rack was being stored near the west perimeter wall of the production room, where rodent activity was observed.
v. Two REPs on one tray and one REP on another tray were observed on an unused rack underneath plastic sheets. Racks of unpackaged bread ready for delivery were being stored within one inch of the plastic covered rack.
vi. The cleaning crew placed a rack of un-packaged bread left from the evening before into the northwest corner of the production room less than 36 inches from a five gallon bucket that was being used as a homemade rodent trap. Two partially decayed rodents were floating in four inches of putrefied liquid. The rack remained in this location when the morning cleaning crew left for the day.
vii. Four unshielded spring loaded traps baited with cheese were within forty-eight inches of a rack of uncovered baked bread products. On the floor were bits of cheese which came within thirty-six inches of the baked bread products.
viii. There were at least 106 REPs on an unused baguette style rack being stored near the west perimeter wall, and about twenty feet from the north wall.
ix. There were at least 96 REPs located within a five by five foot area on the floor next to the west perimeter wall where a bread rack was moved to be used for production.
x. There were at least 40 REPs located next to an unused rack covered with a plastic sheet, located next to the west perimeter wall near the four unshielded spring loaded traps.
xi. There were at least 40 REPs and pieces of insulation material located on top of the middle oven located on the south wall.
xii. There were at least 36 REPs located on and around an unused table-top bread slicer located in the southwest corner.
b. In the production mezzanine:
i. There were at least 17 REPs and apparent nesting material found on top of a fan or air conditioner housing, located in the northwest corner.
ii. There were at least 37 REPs within a three by twenty-five inch area behind stored metal trays against the west perimeter wall about four feet from the south wall.
iii. Ingredients in closed cardboard cartons (lemon peel glace, raisins, yeast, baking powder, and cinnamon) as well as closed plastic containers, were on the same shelf and approximately twelve inches from a dead rodent pinned in a homemade spring trap.
iv. Five live small red insects were observed, four on a cardboard box containing raisins, and one on top of a cardboard box of glace lemon peel. In addition, eight live small red insects and two dead ones were found on top of a plastic storage container lid covered with food residue. Finally, eleven live small red insects, one dead insect, and one apparent larva, were seen on the top surface of three containers of Panzanella Stollen Sleeves used to pack finished product.
c. In the maintenance mezzanine, there were at least 48 REPs within a two by two foot area located behind white 5 gallon buckets on the floor adjacent to the south perimeter wall, where there was a hole in the wall insulation lining.
2. Your firm failed to provide adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). Specifically, our investigator observed the following potential pest routes:
a. Two holes in the sheet rock located at the south floor/wall juncture, four feet from the southwest corner of the production room, directly behind a table top bread slicer. The largest hole was one inch by one inch.
b. A six inch by thirty inch opening above the building support beam between the dough mixing station and oven staging area in production room.
c. A five inch by forty-eight inch gap between the spiral staircase and production mezzanine floor.
d. A two inch by two inch gap at the production room entrance strip curtain with a bent metal door flashing.
e. A two inch by two inch hole at the base of the maintenance mezzanine stairs and next to the main door leading to the spiral staircase.
f. Two holes in the ceiling located directly over the oven staging area in the production room. The largest hole is about eight inches by five inches and our investigator observed insulation hanging over uncovered dough.
g. Five holes in the ceiling on the production mezzanine level above and near the old fan/air condition where REPs and nesting material were found. The largest hole is about ten inches by four inches.
h. One hole on the south perimeter wall of the maintenance mezzanine which was about five inches by three inches.
3. You failed to clean all food-contact surfaces, including utensils and food-contact surfaces of equipment as frequently as necessary to protect against contamination of food as required by 21 CFR 110.35(d). Specifically, our investigator observed the following conditions:
a. There was food residue, oil, and dirt on contact surfaces of several pieces of equipment including, but not limited to the baguette pans, pan bread pans, flat bread rack trays, canvas bread baking sleeves, (b)(4) section dough divider, (b)(4) bread slicer, metal flour bowls, and flour scoops.
b. There was food residue and dirt found on a table top food scale, bread rack frames, framework and base of (b)(4) section dough divider, housing of the free standing (b)(4) dough rounder, the stand for the large floor dough mixer, the legs of the work table at the dough mixing station, the handles and lids of the (b)(4) gallon plastic ingredient containers, and the stainless steel rolling ingredient caddies under the dough mixer work station.
c. There were REPs on unused shelves of bread rack found after the rack had been used during the production day and returned to storage.
d. Racks of uncovered baked bread were being stored next to empty racks that had been used in production. The empty racks had oil soaked parchment paper lined trays with an accumulation of flour and residue. The frames of the empty racks and trays also had an accumulation of food residue.
e. An unused rack located in the northwest corner had an accumulation of what appeared to be corrosion and food residue. The cloth sheet pans used on the rack had an odor of rancid oil, and were dark colored instead of the cream color.
4. Your firm failed to properly store equipment that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant building or structures, as required by 21 CFR 110.20(a)(1). Our investigator observed unused and broken equipment in the production room and production mezzanine which created potential harborage areas for pests as evidenced by the following:
a. Several pieces of unused equipment were found in the production room where rodent activity was found. This equipment included the (b)(4) bread slicer, (b)(4) dough roller, (b)(4) portable conveyor, (b)(4) food processing equipment, upright bagel style bread rack, and one rack covered with plastic sheeting.
b. Corroded metal trays and particle board were stored against the wall, and other pieces of equipment including bread racks and a table, were found in the production mezzanine area next to stored food items.
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). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
You should take prompt action to correct these violations, and you should establish procedures whereby such violations do not recur. Failure to correct these violations may result in regulatory action without further notice, including seizure or injunction.
You should notify this office in writing, within 15 working days from receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent recurrence. You should include photographs and records, including pest control records and records of repair to equipment, and any other useful information to assist us in evaluating your corrections. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.
Section 743 of the Act (21 USC 379j-31) authorizes FDA to assess and collect fees to cover costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 USC 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021. If you have questions regarding any issue in this letter, please contact Lisa M. Elrand at (425) 302-0415.
Ann M. Adams, PhD
Acting District Director
cc: Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560