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WARNING LETTER

La Sabrosita Company Inc 02/02/2016

La Sabrosita Company Inc - 02/02/2016


Recipient:
La Sabrosita Company Inc


United States

Issuing Office:
Baltimore District Office

United States


  

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

Public Health Service
Food and Drug Administration
 
Baltimore District Office
6000 Metro Drive
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5705

 

Warning Letter
CMS # 481090
 
February 2, 2016
 
Ms. Argentina Ortega
President/Owner
La Sabrosita Company Inc. (dba La Sabrosita Bakery)
7730 Midlothian Turnpike
North Chesterfield, VA 23235-5172
FEI: 3002924727
 
Ms. Ortega,
 
The United States Food and Drug Administration (FDA) inspected your food manufacturing facility, La Sabrosita Company Inc. (dba La Sabrosita Bakery), located at 7730 Midlothian Turnpike, North Chesterfield, VA 23235-5172 on July 20, 22-24, 2015. FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 [21 CFR Part 110]. At the conclusion of the inspection, you were issued a Form FDA-483, Inspectional Observations, which documented insanitary conditions in your facility at the time of the inspection. Based on FDA’s inspectional findings documented during the inspection, we determined that your bakery products are 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 they were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health.
 
Furthermore, during the inspection our investigator obtained the labels that your firm uses for your “Cheese Bread (Quezadilla); Pound Cake (Torta Alemana); and Pastel Tres Leches” products. We have reviewed the labels and found them in violation of the food labeling regulations, Title 21, Code of Federal Regulations, Part 101 [21 CFR Part 101], which causes your products to be misbranded within the meaning of Section 403 of the Act, [21 U.S.C. § 343]. You may find the Act and FDA’s regulations through links in FDA’s home page at www.fda.gov.
 
Your significant violations are as follows:
 
Misbranding Violations:
  1. Your Pound Cake (Torta Alemana), Pastel Tres Leches and Cheese Bread (Quezadilla) products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the labels fail to declare all major food allergens present in the products, as required by section 403(w)(1) of the Act.
Section 201(qq) of the Act [21 U.S.C. § 321(qq)] defines 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 the exception of highly refined oils, as "major food allergens." 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 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 (e.g. “Whey (Milk))”, 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)].
Your food labels fail to declare the following major food allergens specified by the Act:
 
Wheat: Your Pound Cake (Torta Alemana) and Pastel Tres Leches products declare “Cake Mix Flour” and “Flour,” respectively, which contain wheat.
 
Furthermore, your “Contains” statements for your Pound Cake (Torta Alemana) and Cheese Bread (Quezadilla) products are not correct. If a “Contains” statement is used on a food label, the statement must include the names of the food sources of all major food allergens used as ingredients in the packaged food. In addition, section 403(w)(1) of the Act requires that the “Contains” statement be followed by the names of the food sources from which the major food allergen is derived.
  • The “Contains” statement for the Pound Cake states “Contains allergens: soybean oil”; this statement fails to list wheat, milk and egg. Additionally, “Soybean oil” is not an acceptable name of the food source which is “soybeans.”
  • The “Contains” statement for the Cheese Bread (Quezadilla) states “Contains allergens: wheat flour, milk, soybean oil”; this statement fails to list egg. Additionally, “wheat flour” and “soybean oil” are not acceptable names of the food sources which are “wheat” and “soybeans.” We also note that the “Contains” statement declares “milk”; however, we question which of the ingredients as listed in the ingredient statement would contain milk protein.
  1. Your Pastel Tres Leches, Pound Cake (Torta Alemana), and Cheese Bread (Quezadilla) products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the labels fail to bear the required nutrition information in 21 CFR 101.9.
Specifically, the nutrition labels do not identify the quantitative amounts of any of the nutrients, as required per 21 CFR 101.9.
  1. Your Pound Cake (Torta Alemana), Pastel Tres Leches and Cheese Bread (Quezadilla) products are misbranded within the meaning of section 403(f) because your product labels contain information in two languages, but do not repeat all the required label information in both languages.
    • Your Pastel Tres Leches product does not bear a statement of identity in English in accordance with 21 CFR 101.15(c).
    • Your Pastel Tres Leches, Pound Cake (Torta Alemana) and Cheese Bread (Quezadilla) products contain representation in Spanish, but do not declare all required elements in Spanish. In accordance with 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.
  1. Your Pound Cake (Torta Alemana), Pastel Tres Leches and Cheese Bread (Quezadilla) products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because they are fabricated from two or more ingredients and the labels fail to declare the common or usual name of each ingredient, as required under 21 CFR 101.4.
Specifically, for your Pound Cake product:
  • The ingredients are not declared in descending order of predominance by weight [21 CFR 101.4(a)(1)]. The label declares “contains 2% or less of” ingredients such as salt, mono and diglycerides, preservatives, flavors, and colors before the cake flour ingredient and eggs.
  • “Cake mix flour” is not the appropriate name for this ingredient in your product. Based on the specification sheet provided during the inspection, this is actually bleached enriched flour, which is a standardized food under 21 CFR 137.165.
  • The sub-ingredients of the multi-component ingredients “cake mix flour” and “baking powder” are not declared [21 CFR 101.4(b)(2)]. 
For your Pastel Tres Leches product:
  • The ingredient statement declares “whole eggs” as an ingredient, but this is not the common or usual name for “eggs” [21 CFR 101.4(a)(1)].
  • “Buttercreme” is not an appropriate common or usual name of an ingredient. Based on an internet search, this is a brand name for an icing.
  • The sub-ingredients of the multi-component ingredient “baking powder” are not declared [21 CFR 101.4(b)(2)].
  • We question whether the ingredients are declared in descending order of predominance by weight. 
Cheese Bread (Quezadilla):
  • The Cheese Bread is made with grated parmesan romano cheese; this ingredient and its sub-ingredients are not listed on the label [21 CFR 101.4(a)(1)].
  • Based on the sub-ingredients declared for the “wheat flour,” the wheat flour is not declared by the appropriate name for that ingredient. The standard for wheat flour under 21 CFR 137.105 does not permit many of the sub-ingredients that are declared on the label. The appropriate name for this food may be bleached enriched bromated flour, which is a standardized food under 21 CFR 137.160. One of the sub-ingredients declared for the wheat flour is “enriched niacin.” We question whether this is the correct name for this sub-ingredient.
  1. Your Pastel Tres Leches product is misbranded within the meaning of section 403(i)(1) because the statement of identity “Pastel Tres Leches” is not appropriate for this food. Pastel Tres Leches translated to English means “Three Milk Cakes.” This cake is characterized by a sauce made from evaporated milk, sweetened condensed milk and milk or cream. However, based on the ingredient list, this cake is not made with any type of milk. Therefore, the statement of identity is not the appropriate common or usual name for this food and is not an appropriately descriptive term [21 CFR 101.3(b)].
  1. Furthermore, your Pastel Tres Leches product is misbranded within the meaning of section 403(a)(1) because the statement of identity “Pastel Tres Leches” is a false description of the product. Specifically, the statement of identity translates to “Three Milks Cake” as stated above, but according to the ingredient statement, the product does not contain milk. .
CGMP Violations:
  1. Your firm failed to hold food that can support the rapid growth of undesirable microorganisms in a manner that prevents the food from becoming adulterated within the meaning of the Act, as required by 21 CFR Part 110.80(b)(3). Specifically, our investigator observed a temperature reading of 46°F on the digital thermometer located on the outside of your only walk-in-cooler. When our investigator checked your cooler temperature, with a calibrated thermocouple, a reading of 47.9°F was obtained. The contents of the cooler included: more than 30 dozen eggs, more than 10lbs of grated cheese, three gallons of milk and mixed dough. Cold holding and storage temperatures at your facility of these perishable food items do not meet the requirement for maintaining refrigerated foods at 45°F (7.2°C) or below as appropriate to effectively control pathogenic bacteria growth and toxin formation. This observation has been previously noted as a repeat violation on May 4, 2015 and October 16, 2014.
  1. Your firm failed to perform filling, assembling, packaging, and other operations in a manner that protects food from becoming contaminated, as required by 21 CFR Part 110.80(b)(13). Specifically, our investigator observed a pile of leaking trash in the receiving area of the warehouse, approximately three inches from cooling uncovered, finished bakery product. A firm employee was observed throwing an empty ingredient container from approximately 10 feet onto the trash pile. Additionally, our investigators observed a tray of uncovered, finished bakery products set across the lip of an uncovered trash can in the packaging area. These observations have been previously noted as a repeat violation on October 28, 2013, January 10, 2011, and November 18, 2010.
  1. Your firm failed to operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food, food-contact surfaces, and food packaging materials, as required by 21 CFR Part 110.20(b)(6). Specifically, our investigator observed a fan in your walk-in cooler with accumulation of debris and dust, blowing air onto uncovered finished bakery products, and a tray of uncovered bakery products waiting to go into the oven situated under a fan with accumulation of debris and dust. This observation has been previously noted as a repeat violation on October 28, 2013.
  1. Your firm failed to provide alternate means to the toilet doors that open into areas where food is exposed to airborne contamination, as required by 21 CFR Part 110.37(d)(4). Specifically, our investigator observed the bathroom doors open outward into the hallway approximately three feet from the uncovered finished bakery products cooling on the mobile tray trolleys. This observation has been previously noted as a repeat violation on October 16, 2014.  
This letter may not list all of the violations at your facility. You are responsible for ensuring your processing plant operates in compliance with the Act and the Current Good Manufacturing Practice regulation (21 CFR Part 110) and Nutrition Labeling regulations (21 CFR 101.9). 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. Failure to do so may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.  
 
In addition to the above violations, we have the following comment:
  • The weight in pounds or ounces for your Pound Cake (Torta Alemana), Pastel Tres Leches and Cheese Bread (Quezadilla) products should be followed by the metric equivalent (i.e., grams) in parenthesis [Fair Packaging and Labeling Act, 15 U.S.C. § 1453(a)(2)].
You should respond in writing within fifteen (15) working days from receipt of this letter. Your response should outline the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent their recurrence. Include any documentation necessary to show that correction has been achieved. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections.
 
Additionally, 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 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 reply should be directed to Ms. Evelyn Bonnin, District Director, Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have any questions regarding this letter, please contact CDR Rochelle B. Young, RPh, MSA, Compliance Officer, at (410) 779-5437 or rochelle.young@fda.hhs.gov
 
Sincerely,
/S/                                                         
Evelyn Bonnin
District Director
Baltimore District