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  5. Douce France Bakery - 05/19/2016
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WARNING LETTER

Douce France Bakery


Recipient:
Douce France Bakery


United States

Issuing Office:
San Francisco District Office

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
San Francisco District Office
1431 Harbor Bay Parkway
Alameda, CA 94502
Telephone: (510) 337-6700
FAX: (510) 337-6703

 

Warning Letter
 
 
VIA OVERNIGHT DELIVERY
SIGNATURE REQUIRED
                                                                                                                                              
                                                                                                
May 19, 2016
 
Mr. Mauro R. Ferreria
President and Owner
Douce France, Inc., dba Douce France Bakery
686 Broadway St
Redwood City, CA 94063
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].
 
Adulteration
 
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.
 
Misbranding
 
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.
 
Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines a major food allergen as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with certain exceptions, e.g., highly refined oils derived from a major food allergen. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
  • The word “Contains,” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients [section 403(w)(1)(A) of the Act, 21 U.S.C. § 343(w)(1)(A)], or
  • The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) [section 403(w)(1)(B) of the Act, 21 U.S.C. § 343(w)(1)(B)].
Specifically, your “Tart Shells” product is manufactured using butter, which contains milk; however, you fail to declare milk on your finished product label.
 
This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing systems. You should investigate and determine the causes of the violations and take prompt actions to correct the violations to bring your products into compliance. Failure to promptly correct these violations may result in legal action without further notice including seizure and injunction.
 
We offer you the following labeling comment:
  • 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.
 
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
 
Your written response should be directed to:
 
Lawton W. Lum
Director of Compliance
1431 Harbor Bay Parkway
Alameda, California 94502
 
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. 
 
Sincerely,
/S/ 
Kathleen M. Lewis, J.D.
District Director