Inspections, Compliance, Enforcement, and Criminal Investigations
Biofournil Of America Inc. 4/18/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Ave SE, Suite 210
Bothell, WA 98021
April 18, 2013
In reply refer to Warning Letter SEA 13-17
Jean-Yves Fouche, Owner
Biofournil of America, Inc., dba Boulangerie Nantaise
La Camusière - 49600 Le Puiset Doré
Dear Mr. Fouche:
The United States Food and Drug Administration (FDA) conducted an inspection of your bakery located at 2507 4th Ave, Seattle, Washington on February 19, 2013, through March 14, 2013. During the inspection, the FDA investigator documented serious violations of the Current Good Manufacturing Practice regulations for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). The inspection revealed that food stored at your facility is adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that the food products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth. You can find the Act and its associated regulations on the internet through links on the FDA web page at www.fda.gov.
In addition, sample INV 791135, a filth exhibit, collected during the inspection, was analyzed by FDA’s Pacific Regional Laboratory Northwest. Laboratory analyses confirmed the presence of adult red flour beetles collected at the base of an oven and mouse excreta pellets collected from seven different locations at your facility including the base of a large mixer and the floor next to a pallet of flour for use in production of your bakery products.
The following significant violations were observed during the inspection:
1. You failed to take effective measures to exclude pests from your facility and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c).
- At least 16 dead insects were observed in the baking and proofing area on February 19, 2013. At least 20 live insects were observed moving along and under the south and southeast wall of the baking oven cement pad ledge within 12 inches of racks where bread dough is placed on trays during production. Two live insects were observed behind the (b)(4) proofer and one live insect was observed near the door of the proofer. Insect trails were observed between the oven and west wall of the baking and proofing area and behind the proofer.
- Mouse excreta pellets were collected at seven different locations in your production facility on February 19 and 20, 2013. Mouse excreta pellets and apparent rodent urine stains and tracks were observed during the inspection including the following:
- Seven mouse excreta pellets were observed on the base of a mixer during processing of bread dough;
- No less than 80 mouse excreta pellets, apparent rodent fluorescing urine stains and trails, and apparent rodent tracks were observed on the oven cement pad behind the oven and adjacent to the west wall of the baking and proofing area;
- Nine mouse excreta pellets were observed no more than 12 inches from two metal baking racks loaded with baking trays and cloth that contacts bread during production;
- Approximately 200 mouse excreta pellets were observed inside the dough production area at the east wall;
- Four mouse excreta pellets were observed behind the (b)(4) proofer in the baking and proofing area;
- Thirteen mouse excreta pellets were observed on the southeast floor of the dry ingredient storage area within 12 inches of a pallet containing fifty-pound bags of flour used for bread and pastry production and thirteen mouse excreta pellets were observed in the northwest corner of the dry ingredient storage area; and
- Approximately 150 apparent rodent excreta pellets were observed while the bakery was in production along the floor/wall junctures behind each reach-in freezer and refrigeration unit, under the three-compartment sink, under shelving in the dry ingredient storage area, and along each wall in the dough production area.
2. You failed to maintain equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food in a manner that protects against contamination, as required by 21 CFR 110.80 (b)(7).
- A dough hook was suspended in an elevated waste water drain;
- A wooden baker’s peel used to move bakery items to and from the oven and two wooden utensils stored ready for use contained cracks and gouges;
- A (b)(4) mixer used daily had a cracked and broken upper casing repaired with tape located over the mixing bowl; and
- A plastic bin holding bread dough in a transparent plastic bag was resting directly on the production area floor.
3. Your utensils are not made of materials or designed to allow proper cleaning, as required by 21 CFR 110.40(a).
- Transparent plastic bags stockpiled in the bakery production area were observed repeatedly used for bread dough production and contained bits of dried raw dough;
- Soiled triangular cardboard cutouts were observed ready for use and your employee stated the cutouts are repeatedly used as a pattern to cut out croissant dough by laying the cardboard directly on the sheeted dough.
4. You failed to properly store toxic compounds in a manner that protects against contamination of food, food-contact surfaces, or food packaging material, as required by 21 CFR 110.35(b)(2).
- A half-full can of acetone was observed stored on a cart in the baking and proofing area next to parchment paper and a plastic bag used to hold dough during production; and
- (b)(4) cans of butane fuel were observed stored on a rack above ingredients such as poppy seeds, sesame seeds, and herbs in the baking and proofing area.
5. Each facility shall be equipped with adequate sanitary facilities and accommodations including hand-washing facilities, as required by 21 CFR 110.37(e).
Specifically, the hand sink located in the dough production area did not contain hand soap. Additionally, the sink was blocked by carts and refuse containers, while delivery drivers were observed to place baked demi baguettes into brown bags with bare hands for delivery to local restaurants.
6. Your plant and facility is not constructed in such a manner as to allow ceilings to be adequately cleaned and kept clean and kept in good repair, as required by 21 CFR 110.20(b)(4).
Specifically, ceiling tiles were observed missing in bakery production and dry ingredient storage areas as follows:
- Missing tiles above the (b)(4) oven including the front of the oven where unfinished and finished product is moved in and out of the oven;
- Missing tiles above the cooking/processing area above the south door of the proofer where raw products pass through before baking; and
- Soiled tile directly above small proofer where racks of raw product are moved in and out.
7. You failed to clean non-food-contact surfaces of equipment used in the operation of food plants as frequently as necessary to protect against contamination of food, as require by 21 CFR 110.35(d)(3).
Specifically, the investigator observed heavily soiled areas at the base of the (b)(4) mixer, at the floor/wall junction of the (b)(4) oven, and under the refrigerators and freezers. Accumulations of white powdered dry ingredient build up, food debris, and pest filth including insect tracks were observed in these places.
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. While these violations were documented during the most recent inspection of your facility, we note that similar deviations were documented during previous inspections.
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.
Section 743 of the Act (21 U.S.C. § 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 U.S.C. § 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.
Your written response should be sent to Lori J. Silverstein, Acting Compliance Officer, U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021. If you have questions about this letter, please contact Acting Compliance Officer Lori Silverstein at 425-302-0472.
Charles M. Breen
Frederic Dupont, General Manager
Biofournil of America, Inc., dba Boulangerie Nantaise
2507 4th Ave
Seattle, Washington 98121-1437
Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560