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  5. F. & S. Maranto, LLC - 424153 - 08/05/2014
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WARNING LETTER

F. & S. Maranto, LLC MARCS-CMS 424153 —


Recipient:
F. & S. Maranto, LLC


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
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5707

 

WARNING LETTER
CMS# 424153
 
August 5, 2014
 
Via UPS
 
Mr. Salvatore E. Maranto, President/Co-Owner
F & S Maranto, LLC.
244 Pearl Street
Baltimore, MD 21201
 
Dear Mr. Maranto:
 
We inspected your firm, a manufacturer of ready-to-eat (RTE) bread products located at 244 Pearl Street in Baltimore, MD on February 25, 27, March 6, and 7, 2014. The inspection found significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulation for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110).  These violations cause the foods manufactured at your facility to be 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 contaminated with filth or rendered injurious to health.  Furthermore, FDA conducted a review of labeling for your Kaiser rolls and hearth (Italian) bread products and found significant violations of the labeling regulations for foods, Title 21 CFR 101.  These violations cause your Kaiser rolls and hearth (Italian) bread to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343].  You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.
 
Adulterated Food
 
Specifically, our inspection of your facility revealed the following cGMP violations:
 
1.)    Appropriate training in food handling techniques and food protection principles has not been provided to food handlers and supervisors, as required by 21 CFR 110.10(c). Specifically, your firm’s supervisor, who oversees production, has not been trained in areas dealing with food safety. This same observation was also cited during our previous inspection of your firm, which ended April 9, 2013.
 
2.)    Failure to manufacture and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms or contamination of food, as required by 21 CFR 110.80(b)(2). Specifically, your firm’s steam room was observed on February 25, 2014 to have drips forming on racks used to store bread pans, which are not cleaned with detergent or sanitizer. The drips were observed falling down on top of raw sub rolls in the steam room.  This same observation was also cited during our previous inspection of your firm, which ended April 9, 2013.
 
3.)    Failure to maintain equipment and utensils in an acceptable condition through appropriate cleaning and sanitizing, as required by 21 CFR 110.80(b)(1). Specifically,
 
a.    It was observed that your firm does not utilize a sanitizer on any of the equipment or utensils used to manufacture Kaiser rolls, bread, and sub rolls.
b.    On February 25, 2014, an employee was observed cleaning the (b)(4) with a degreaser that has a label stating that food contact surfaces should be rinsed thoroughly with potable water before re-use. The employee cleaning the (b)(4) did not rinse it with potable water after the degreaser was applied.
 
4.)    Failure to maintain buildings in repair sufficient to prevent food from becoming adulterated, as required by 21 CFR 110.35(a). On February 25, 2014, a tarp was hung above the (b)(4) directly above where raw Kaiser roll dough is exposed during manufacturing. Your firm’s supervisor indicated that the tarp was hung because the roof was leaking and the tarp diverted the leak into a trash can.
 
Misbranded Food:
 
1.    Your Kaiser roll 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 allergens, “wheat” and “milk,” as required by 403(w) 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 ingredients containing proteins derived from one of these foods, with the exception of highly refined oils or ingredients derived from such 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., “flour (wheat)”), 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 that 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 Kaiser roll product is manufactured using (b)(4), which contains wheat, and (b)(4), which contains milk.
 
2.    Your Kaiser roll product is misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C.  § 343(i)(1)] in that the label fails to bear the common or usual name of the food. Specifically, your product label does not provide a statement of identity of the food in accordance with 21 CFR 101.3.
 
If a food meets the provisions of a standard of identity it must be named by the standardized term. The standards of identity for bakery products such as bread, rolls and buns and enriched bread, roll, and buns are found in 21 CFR Part 136.
 
3.    Your Kaiser roll and Hearth Bread products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients but the common or usual name of each ingredient is not declared on the product labels as required by 21 CFR 101.4. For example:
  • Your Kaiser roll product fails to declare any ingredients in the finished product label, as required in 21 CFR 101.4(a)(1).
  • Your Hearth Bread product is manufactured with multi-component ingredients; however, your label fails to declare sub-ingredients of these ingredients in accordance with 21 CFR 101.4(b)(2). Specifically, the ingredients (b)(4), and (b)(4) are multicomponent ingredients that contain two or more ingredients; however, you fail to list all sub-ingredients on your finished product labels.
According to 21 CFR 101.4(b)(2), the requirement to list these component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, or by listing the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
 
4.    Your Kaiser roll product is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product fails to bear the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
 
5.    Your Kaiser roll product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] in that the product fails to bear an accurate statement of the net quantity of the contents in terms of weight, measure, or numerical count in accordance with 21 CFR 101.105.
 
6.    Your Kaiser roll and Hearth Bread products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)]. Specifically:
  • Your Kaiser roll fails to bear nutrition facts information as required by 21 CFR 101.9.
  • Your Hearth Bread product fails to declare the serving size in accordance with 21 CFR 101.9(b)(2) because it is not based on the reference amount customarily consumed (RACC) for breads in 21 CFR 101.12(b), Table 2, which is 50 g. The label declares a serving as “1 oz. (28g/about 1 inch slice).” Since the serving size is incorrect, all of the nutrition values are also incorrect.
7.    Your Kaiser roll product is misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because the product contains a chemical preservative. In accordance with 21 CFR 101.22(j), the label of a food to which a chemical preservative has been added shall bear a declaration of both the common or usual name of the ingredient and a separate description of its functions, e.g., “preservative,” “to retard spoilage,” “a mold inhibitor,” “to help protect flavor” or “to promote color retention.” The ingredient list in the letter you provide to your customers for your Kaiser roll product does not declare the presence of (b)(4) and a description of the function of this ingredient as required.
 
Under 21 CFR 184.1221, (b)(4) is an antimicrobial agent within the meaning of 21 CFR 170.3(o). Under 21 CFR 170.3(o), antimicrobial agents are substances used to preserve food by preventing growth of microorganisms and subsequent spoilage, including fungistats, mold and rope inhibitors, and the effects listed by the National Academy of Sciences/National Research Council under “preservatives.”
             
This letter may not list all the violations at your facility. You are responsible for ensuring you operate in compliance with the Act and all applicable regulations, including the Current Good Manufacturing Practice regulation (21 CFR 110) and food labeling regulation (21 CR 101). 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 all of the violations noted in this letter and establish and implement procedures that will prevent these and other violations in the future. Failure to implement lasting corrective action may result in FDA taking regulatory action such as seizure or injunction without further notice.
 
Additionally, we have the following labeling comments:
 
1.    You stated during the inspection that you provide a letter bearing an all-inclusive ingredient list to your customers receiving sub rolls and Kaiser roll. However, the sub rolls and Kaiser roll have different ingredients; therefore, an all-inclusive ingredient list combining the ingredients of both products into one list is not adequate under 21 CFR 101.4.
 
2.    Your Hearth Bread label declares “sugar (cane or corn).” This is not the appropriate common or usual name of these ingredients because cane sugar and corn sugar are two separate ingredients that cannot be listed collectively under 21 CFR 101.4. In accordance with 21 CFR 101.4(b)(20), the term sugar refers to sucrose which is obtained from sugar can or sugar beets. In accordance with 21 CFR 184.1857, corn sugar is D-glucose or dextrose and is derived from corn starch.
 
3.    Your Hearth Bread label declares “enriched hi-gluten flour,” which is not an appropriate name for this ingredient.
 
4.    Your Hearth Bread nutrition facts panel heading under 21 CFR 101.9(d)(3) is “Servings Per Container,” not “Servings Per Package.”
 
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 reinspection-related cost. A reinspection is one of 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. Reinspection-related costs mean all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection 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 reinspection-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 reinspection-related costs.
 
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations noted above. You should include in your response, documentation and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violation.
 
Please send your reply to the U.S. Food and Drug Administration, Attention: Ernest F. Bizjak, Compliance Officer at the address above. If you have questions regarding any issues in this letter, please contact Mr. Bizjak by phone at 410-779-5715 or by email at ernest.bizjak@fda.hhs.gov.
 
 
 
Sincerely yours,
/S/                                                           
Evelyn Bonnin
District Director
Baltimore District Office