Inspections, Compliance, Enforcement, and Criminal Investigations
Los Genuinos, Inc. 6/2/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Juan District
June 2, 2011
Return Receipt Requested
Mr. Nicolás Rivera Berríos, Owner
Los Genuinos, Inc.
454 Dr. Hiram Gonzalez Street
Bayamon, PR 00959
Dear Mr. Rivera:
The U.S. Food and Drug Administration (FDA) inspected your food manufacturing facility located at 454 Dr. Hiram Gonzalez Street, Bayamon, Puerto Rico 00959, from January 11 to 25, 2011. During the inspection, our investigator observed serious violations of Title 21 of the Code of Federal Regulations, Part 110 (21 CFR 110), Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food. Because your food products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or may have been rendered injurious to health, your food products are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (Act) [21 U.S.C. § 342(a)(4)].
In addition, during the inspection, our investigator collected labels for several of your food products. Our review of the labels and other evidence collected during the inspection indicate that your Los Genuinos Mantecaditos 4 oz. and 6 oz. products are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. Further, your Los Geniunos Mantecaditos 6 oz. product is adulterated within the meaning of section 402(c) of the Act [21 U.S.C. 342(c)] because it bears or contain an unsafe color additive. You may find the Act and FDA regulations in the CFR through links in FDA's website at http://www.fda.gov.
1. To comply with 21 CFR 110.35(c), you must take effective measures to exclude pests from your food processing areas and protect against the contamination of food on the premises by pests. However, during the inspection, our investigator observed the following:
a. Flies in the processing area on food contact surfaces, such as the dough dispensing machine;
b. Ants on the ingredient mixing table;
c. Adad Spider webs below the ingredients holding table, the electronic panel above the table, and on the ceiling and walls of the processing area;
d. An industrial fan used by your firm to cool down baked products was located on the floor of the storage area in close proximity to a rodent bait station. The floor area around the fan contained excreta pellets, dead insects, birth feathers, and filth. The fan drew in this debris and filth from the floor as it blew air onto three racks of your unpackaged food products.
2. To comply with 21 CFR 110.20(b)(7), you must provide adequate screening or other protection against pests. However, during the inspection, our investigator observed the following:
a. A screened gate leading to the backyard of the facility was open. In the immediate proximity of the opened gate, there were live birds and flies. Files were observed entering your production area through this entrance.
b. The window screens in the processing, storage, and dispatching areas did not correctly fit to the window frames allowing for gaps of approximately one-half of an inch wide.
3. To comply with 21 CFR 110.35(a), you must ensure that your building, fixtures, or other physical facilities are maintained in a sanitary condition and kept in repair sufficient to prevent food from becoming adulterated. However, during the inspection, our investigator observed that sections of the ceiling above the manufacturing area were missing or had peeling paint. The ceiling also had water filtration problems and packaging materials for your food products showed signs of water damage. In addition, our investigator observed that the windows and screens in the production and dispatching areas had an accumulation of bird excrement, feathers, and dust.
4. To comply with 21 CFR 110.20(b)(5), you must provide safety-type light bulbs, fixtures, skylights, or otherwise protect against food contamination in case of glass breakage. However, our investigator observed that the light fixtures used in your facility lacked protective covering that prevent broken glass from falling into raw materials, in-process products, and finished products.
5. To comply with 21 CFR 110.37(e), your plant must be equipped with an adequate and convenient hand-washing facility and furnished with running water at a suitable temperature. However, during the inspection, our investigator observed that the employees’ bathrooms had no hot water.
- Your Los Genuinos Mantecaditos 6 oz. product is adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because the product bears or contains a color additive which is unsafe within the meaning of section 721(a) of the Act [21 USC § 379(a)]. Section 721(a) deems a color additive to be unsafe unless its use is in conformity with the color additive’s listing regulation. Your Los Genuinos Mantecaditos 6 oz. product contains FD&C Yellow No. 5. 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)]. However, the label for the product fails to declare the presence of FD&C Yellow No. 5 in the ingredient statement.
- Your Los Genuinos Mantecaditos 4 oz. and 6 oz. 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 the major food allergen, wheat, as required by section 403(w)(1) of the Act. Section 201(qq) of the Act [21 U.S.C. § 321(qq)] defines as “major food allergens” 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. 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., “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 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 Los Genuinos Mantecaditos 4 oz. and 6 oz. products contain enriched flour, which contains wheat. However, the labels for these products fail to declare the presence of wheat, which is a major food allergen.
- Your Los Genuinos Mantecaditos 4 oz, and 6 oz. 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, but the labels fail to bear the common or usual name of each ingredient, as required by 21 CFR 101.4. Specifically:
- During the inspection, you certified that your Los Genuinos Mantecaditos 4 oz. product contains “shortening;” however the label for your product does not accurately declare shortening as an ingredient. Under 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).”
- Your Los Genuinos Mantecaditos 4 oz. and 6 oz. products, contain enriched flour, which is a standardized, multi-component ingredient; however, your finished product label fails to declare the sub-ingredients. 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.
- Your Los Genuinos Mantecaditos 4 oz. and 6 oz. products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. 343(q)] in that the labels for these products fail to provide nutrition information in accordance with 21 CFR 101.9. Specifically, the declaration of the number of servings per container is not in accordance with 21 CFR 101.9(b)(8). The number of servings per container must be rounded to the nearest whole number, except for the number of servings between 2 and 5, which should be rounded to the nearest 0.5 serving. However, the number of servings per container declared on the labels for your products is 5.25
This letter is not meant to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that your facility and products comply with the Act and its implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice, such as seizure or injunction.
In addition, we note the following:
- In accordance with 21 CFR 101.15(c)(2), if a food product label contains any representation in a foreign language, 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 product is distributed solely in Puerto Rico, it is acceptable for it to be labeled solely in Spanish [21 CFR 101.15(c)(1)]; however, if it contains any information in another language, such as English, all of the required label information must appear in both languages.
- We note that your Mantecaditos products are manufactured with “shortening” which contains partially hydrated soybean oil and cottonseed oils. Soy is a major food allergen and is therefore subject to the allergen source labeling requirements of the Food Allergen Labeling and Consumer Protection Act (FALCPA). 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. Additional information about allergen source labeling is available on our website at http://www.cfsan.fda.gov/~dms/wh-alrgy.html.
- Your declaration of the number of servings per container on the label for your Los Genuinos 4 oz. product is 5.25 servings. Based on the declared serving size of 2 cookies (32 grams), the servings per container should be 3.5.
We acknowledge your decision to recall your Los Genuinos Mantecaditos 6 oz. products and the on the spot corrections completed during the inspection. Nonetheless, we are concerned with the repeat violations observed at your facility during inspections conducted on September 2004 (Puerto Rico Department of Health Environmental Division), March and December 2007, as well as the inspection on January 2011, and your firm’s failure to correct these violations.
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 the above violations. You should include in your response documentation, such as records, labels, or photographs, of the corrective and preventive actions taken by your firm, or 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 violations.
Your written reply should be addressed to the Food and Drug Administration, Attention: Carlos A. Medina, Compliance Officer, at 466 Fernández 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 email@example.com.
Maridalia Torres Irizarry
San Juan District Office