Inspections, Compliance, Enforcement, and Criminal Investigations
Corporacion Los Hermanos, Inc. (DBA Panaderia America) 7/8/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|San Juan District
466 Fernandez Juncos Avenue
San Juan Puerto Rico 00901-3223
July 8, 2009
Return Receipt Requested
Mrs. Rosinin Rodriguez
Corporaci6n Los Hermanos, Inc.
DBA Panaderia America
243 Cl Paris
San Juan, PR 00917-3632
Dear Mrs. Rodriguez:
The Food and Drug Administration (FDA) inspected Corporaci6n Los Hermanos, Inc. DBA as Panaderia America food manufacturing facility, located at # 411 America Street corner Paris Street, Urb. Floral Park, San Juan, Puerto Rico 00917, from February 4 to 19,2009. The inspection was con4ucted to assess your compliance with the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 301 et seq.] and applicable implementing regulations found in Title 21 of the Code of Federal Regulations (CFR).
During the inspection, our investigators collected labels for your food products. Our review of the labels and other evidence collected during the inspection found products adulterated and or misbranded within the meaning of Section 402 and Section 403 of the Act respectively [21 U.S.C. §§ 342 and 343] . You may find the Act and FDA regulations in the CFR through links in FDA's website at http://www.fda.gov.
Your Medianoche and hamburger bread products are adulterated within the meaning of section 402(c) of the Act [21 U.S.C. 342(c)] because the products bear or contain a color additive which is unsafe within the meaning of section 72 1(a) of the Act [21 USC 37ge(a)]. Section 721 (a) deems a color additive to be unsafe unless its use is in conformity with the color additive's listing regulation. Specifically, the listing regulation for FD&C Yellow No.5 requires that the color additive be listed by that name in the ingredient list on the labels of foods for human use [21 CFR 74.705(d)(2)]. Your Medianoche and hamburger bread products are manufactured with National Topaline Egg Shade #431 ingredient, which contains FD&C Yellow No.5; however, the labels for these products fail to declare the presence of FD&C Yellow No.5 in the ingredient statements.
Your Medianoche and hamburger bread products are misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)] because the products bear or contain an artificial flavoring, coloring, or chemical preservative. In accordance with 21 CFR 101.22(k) the label of a food to which any coloring has been added shall declare the coloring in the statement of ingredients. Your Medianoche and hamburger bread products are manufactured with Topaline egg shade ingredient containing certified color additives FD&C Yellow No.5 and FD&C Yellow No.6; however, neither product bears a label identifying the presence of these color additives. Under 21 CFR 101.22(k)(l ), certified colors must be declared by the name of the color additive listed in the applicable regulation in part 74 or part 82 of this chapter. The common or usual name may be abbreviated to omit the "FD&C" prefix and the term "No." (e.g., Yellow 5).
Your Pan Especial product contains wheat and milk. Pan Especial is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] in that the label fails to declare the major food allergens, wheat and milk 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 ingredient, 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. "(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 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)].
We also note that your Pan Especial, Pan de Agua, and Pan Sobao bread products are manufactured with "Baker's Special Shortening" which contains soybean oil. As explained above, under Section 201 (qq) of the Act, soy is a major food allergen and is therefore subject to the allergen source labeling requirements under Section 403(w) of the Act.. However, section 201 (qq)(2)(A) of the Act provides an exemption for "highly refined oils"; therefore, highly refined soybean oil would not be subject to the allergen source labeling requirements of Section 403(w). If the soybean oil is not highly refined, however, the product label must declare the presence of soy consistent with section 403(w) of the Act. It is your responsibility to determine whether or not the soybean oil used in your products is highly refined. Additional information about allergen source labeling is available on our website at http://www.cfsan.fda.gov/~dms/whalrgy.html.
Your Pan Especial, Pan de Agua, and Pan Sobao 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 labels fail to bear the common or usual name of each ingredient in the products as specified by 21 CFR 101.4. See 21 CFR 137.105(b)(1), 137.165. For example:
• The labels for your Pan Especial, Pan de Agua, and Pan Sobao products declare "enriched flour"; however, your labels fail to declare the ingredients of the enriched flour.
• Additionally, our investigation found that these products contain "vegetable shortening"; however, the "vegetable shortening" is not declared as required by 21 CFR 101.4(b)(14). Each individual fat and/or oil ingredient of a food intended for human consumption must be declared by its specific common or usual name (e.g. "beef fat," "cottonseed oil") in its order of predominance in the food, except that blends of fats and/or oils may be designated in their order of predominance in the foods as "__shortening" or "blend of__oils," the blank to be filled in with the word "vegetable," "animal," "marine," or combination of these, whichever is applicable if, immediately following the term., the common or usual name of each individual vegetable, animal, or marine fat or oil is given in parentheses, e.g., "vegetable oil shortening (soybean and cottonseed oil)."
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 without listing the ingredient itself. Under the first alternative, 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.
The Pan Especial bread product is further misbranded within the meaning of 403(i)(2) because the ingredient statement bears the term "preservative" as an ingredient; however, the specific preservative is not declared in accordance with 21 CFR 101.22(j). A chemical preservative added to a product must be declared stating both the common or usual name of the ingredient and a separate description of its function, e.g., "preservative."
Your Pan de Agua and Pan Sobao products sold to individual customers are misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. 343] because there is no statement of identity on the Principal Display Panel in accordance with 21 CFR 101.3. The statement of identity for "Pan de Agua" and "Pan Sobao" is listed above the Nutrition Facts panel.
Your Pan Especial product is misbranded within the meaning of Section 403(e)(1) [21 USC 343(e)(1)] in that the package does not contain the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
This letter is not intended to be all inclusive list of violations at your facility. It is your responsibility to ensure that all products marketed by your firm comply with the Act and the applicable regulations. Failure to implement corrective action on 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. You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you have done to correct these violations.
You should include in your respond documentation, such as records, labels, or photographs that document the corrective and preventive actions taken by your firm, or other useful information that would assists 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 violations.
In accordance with 21 CFR 101.15(c)(2), 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. Because your products are distributed solely to Puerto Rico, it is acceptable for them to be labeled solely in Spanish; however, if they contain any information in another language, such as English, all of the required label information must appear in both languages.
Your written reply should be addressed to the Food and Drug Administration, Attention: Carlos A. Medina, Compliance Officer, at 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901~3223. If you have any questions concerning the violations noted please contact Mr. Medina at (787) 474-9538 or by electronic mail at firstname.lastname@example.org.
San Juan District Office