Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/douce-france-bakery-05192016
Timestamp: 2019-08-20 02:23:08
Document Index: 147105430

Matched Legal Cases: ['art 110', 'art 110', '§342', 'art 101', 'art 101', '§ 343', '§ 343', '§ 379', '§ 379']

Douce France Bakery - 05/19/2016 | FDA
Douce France Bakery - 05/19/2016
Douce France Bakery May 19, 2016
FAX: (510) 337-6703
Mr. Mauro R. Ferreria
Douce France, Inc., dba Douce France Bakery
FEI: 3006655394
Dear Mr. Ferreria,
During an inspection of your firm located at 686 Broadway Street, Redwood City, CA 94063-3103 on February 3 through February 5, 2016, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures bread, dessert pastry and other bakery products. During the inspection, our investigators found violations of the Current Good Manufacturing Practice (cGMP) in Manufacturing, Packing, or Holding Human Food regulation, Title 21, Code of Federal Regulations, Part 110 [21 CFR Part 110]. These violations cause the foods manufactured at your facility to be adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. §342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act and its implementing regulations at www.fda.gov.
Additionally, our investigators found that your “Tart Shells” product is not labeled in accordance with FDA’s regulations, Food Labeling, Title 21 Code of Federal Regulations Part 101 [21 CFR Part 101]. These violations cause the product to be misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343].
1. Your firm failed to handle work-in-process in a manner that protects against contamination, as required by 21 CFR 110.80(b)(5). Specifically,
a. An employee was observed manufacturing telera bread, a product that does not contain egg, an allergenic ingredient, using a mixer that was previously used for the production of vanilla tart shell, a product that contains egg, an allergenic ingredient. Furthermore, although an employee removed the visible raw tart shell dough from the sides and bottom of the mixing bowl and the surfaces of the mixing arm, the investigator observed leftover raw tart shell dough at the top of the mixer mixing in with the telera bread dough.
b. A knife used for cutting opera cake was taken from a bucket containing apparent unclean water.
2. Your firm failed to take effective measures to protect against the inclusion of metal or other extraneous material in food, as required by 21 CFR 110.80(b)(8). Specifically,
a. A metal sifter with protruding fraying pieces of metal mesh was used to sift powdered sugar. Although this observation was brought to the attention of management on February 3, 2016, the same sifter was observed sitting on top of a powdered sugar container the next production day. Additionally, investigators observed that your firm does not have a metal detector.
b. A glass light fixture enclosing a light bulb was located directly above ready-to-eat products and raw materials in the refrigerator in the dessert area.
3. Your firm failed to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food and food contact surfaces, as required by 21 CFR 110.35(a). Specifically, work tables made of wood and stainless steel, are not cleaned before sanitizing, they are only wiped down with approximately (b)(4) bleach and water solution.
4. Employees working in direct contact with food and food-contact surfaces did not conform to hygienic practices while on duty to the extent necessary to protect against contamination, as required by 21 CFR 110.10(b). Specifically,
a. While an employee in street clothes and without an apron, removed ready-to-eat vanilla tart shells from shell molds to a baking tray for cooling, our investigators observed the vanilla tart shells came in direct contact with the employee’s street clothes.
b. An employee preparing and hand cutting raw vanilla tart shell dough in street clothes with rolled up sleeves, had exposed arm hair that came into direct contact with the dough.
c. Four employees were observed wearing hair and beard covers with hair exposed outside of the covers during the production of ready-to-eat vanilla tart shells.
d. An employee with approximately ¾” long finger nails with nail polish was observed hand rolling and cutting raw vanilla tart shell dough.
e. Three employees from the morning and evening shifts were observed wearing earrings during the production of vanilla tart shells and telera bread.
5. Your plant is not constructed in such a manner as to allow floors, walls, and ceilings to be adequately cleaned and kept clean and kept in good repair, as required by 110.20(b)(4). Specifically,
a. Standing water was observed on the floor underneath a raw material storage rack containing open and closed bags of dry raw ingredients in the west corner of the production area. Furthermore, apparent mold-like staining was observed in this same corner of the production area, approximately 6” from the open bags of dry raw ingredients.
b. A torn insulation square made of fiberglass material, was hanging from the ceiling directly over the ready-to-eat dessert preparation area.
c. Chipped and cracked wooden baseboards throughout the entire production area and ready-to-eat finished goods storage area.
1. Your “Tart Shells” product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the finished product label fails to declare the major food allergen; milk as required by section 403(w)(1) of the Act.
Specifically, your “Tart Shells” product is manufactured using butter, which contains milk; however, you fail to declare milk on your finished product label.
Tart Shells shipped in bulk form that are not for distribution to consumers in such form and that are for use solely in the manufacture of other foods or that are to be processed, labeled or repacked at a site other than where originally processed or packed are exempt for nutrition labeling under 21 CFR 101.9(j)(9). Tart shells intended for retail sale unless exempt under 21 CFR 101.9(j)(18) would be required to bear nutrition labeling. If none of the tart shells are sold at retail, nutrition labeling is not required. However, if these products are sold at retail nutrition labeling would be required, unless the firm qualifies as a small business.
Section 743 of the Act, 21 U.S.C. § 379j-31, authorizes FDA to assess and collect fees to cover FDA's 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 mean all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the inspection and assessing and collecting the 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.
Refer to the Unique Identification Number CMS case 493724 when replying.
If you have any questions about the content of this letter please contact Ms. Lydia S. Chan, Compliance Officer, at (510) 337-6776.