Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Juan District
NOV 19, 2012
VIA OVERNIGHT Mail
Return Receipt Requested
Mr. Luis Santos Morales
68 Capitan Correa Street
Ponce, Puerto Rico 00730
Dear Mr. Santos:
An inspection of your food manufacturing facility located at 68 Capitan Correa Street, Ponce, Puerto Rico, was conducted on May 29 and 30; and June 4 and 11, 2012 by an Investigator of the United States Food and Drug Administration (FDA). A review of your product labeling found violations that caused the Flan de Coco (Coconut Custard), Cheesecake, and Tres Leches Lymar (Three Milk Cake) products distributed by your firm to be misbranded within the meaning of Section 403 of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 343, in that they are not labeled with the mandatory information required by the Act.
In addition, repeat violations from the Current Good Manufacturing Practices (cGMP) regulation, 21 CFR Part 110, were observed during inspection. These violations cause the products prepared and stored at your facility to be adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or may have been rendered injurious to health. You can find the Act and the CFR through links on FDA’s home page at http://www.fda.gov.
Your significant violations are as follows:
1.Your Flan de Coco, Cheesecake, and Tres Leches Lymar 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. “(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 food labels fail to declare the following major food allergens:
• Flan de Coco – eggs, milk, and coconut
• Cheesecake – eggs and milk
• Tres Leches Lymar –wheat, egg, and soy
Further guidance and information on food allergens can be accessed on FDA’s website at http://www.fda.gov/Food/FoodSafety/FoodAllergens/default.htm.
2.Your Flan de Coco is misbranded within the meaning of Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] because the product fails to bear the common or usual name of the food. Specifically, your Flan de Coco or Coconut Custard product is distributed with no product label that identifies the product as Coconut Custard. Under 21 CFR 101.3 the principal display panel of a food in package form must bear a statement of identity. The statement of identity must be the common or usual name of the food, an appropriately descriptive term, or when the nature of the food is obvious, a fanciful name commonly used by the public for such food.
3.Your Flan de Coco, Cheesecake, and Tres Leches Lymar 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 a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients, as required by 21 CFR 101.4. For example:
• The Flan de Coco and Cheesecake products fail to declare the ingredients used to manufacture each product.
• The Tres Leches Lymar product is manufactured with sponge cake mix, leche condensada, and vanilla topping, which are multi-component foods; however, the label of this product fails to declare the ingredients that comprise these multi-component foods. According to 21 CFR 101.4(b)(2), the requirement to list component ingredients (or “sub-ingredients”) may be met by either (i) parenthetically listing the component ingredients after the common or usual name of the multi-component ingredient, or (ii) by listing the component ingredients without listing the multi-component 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.
4. Your Flan de Coco, Cheesecake, and Tres Leches Lymar products are misbranded within the meaning of section 403(e) in that the products fail to completely declare the name and place of business of the manufacturer, packer or distributer in accordance with 21 CFR 101.5, and fail to declare the net quantity of contents in accordance with 21 CFR 101.105. Specifically,
• The Flan de Coco and Cheesecake fail to declare the name and place of business [21 CFR 101.5].
• The Tres Leches Lymar fails to declare the name of business and zip code [21 CFR 101.5].
• The Flan de Coco and Cheesecake fail to declare the net quantity of contents in the lower third of the principal display panel [21 CFR 101.105].
1. You must take effective measures to exclude pests from the processing areas and protect against the contamination of food by pests to meet the requirements of 21 CFR 110.35(c). However, during the manufacturing of and staging of finished product we observed:
a. Insects webbing on the walls of the production room.
b. A lizard walking on the walls throughout the production room.
c. Several flies and mosquitoes flying around the production room.
2. You must provide your employees with adequate, readily accessible toilet facilities, including hand-washing facilities to comply with 21 CFR 110.37(d). However, there are no hand washing stations for your employees in the production area. In addition, there are no hand towels in the employee restroom. Furthermore, we observed your manufacturing employees handling dirty boxes, bags, street clothes and cleaning tools, then returning to the production room and handling finished ready-to-eat products without washing their hands.
3. Your building must be constructed in such a manner that floors, walls and ceilings may be adequately cleaned and kept clean and in good repair to meet the requirements of 21 CFR 110.20. However, on 5/30/2012 and 6/4/2012 we observed chipped paint directly above unprotected ready-to-eat and in-process products.
4. You must operate fans in a manner that minimizes the potential for contamination to comply with the requirements of 21 CFR 110.20(b)(6). However, we observed standing fans covered with dust blowing air directly over your ready-to-eat products. Your products were unprotected, without lids. Furthermore there were black particles in the sugar your firm used that same day to make caramel.
5. You must conduct food processing in a way to minimize the growth of microorganisms and protect against contamination of food to comply with 21 CFR 110.80(b)(2). However, on 05/29/2012 your firm used aluminum cups with caramel previously served that had been sitting out all night unrefrigerated and unprotected.
6. You must clean and sanitize equipment in a manner that protects against contamination of food and food contact surfaces to comply with 21 CFR 110.35(a); however, we observed employees using a pressurized hose to wash batter containers during the cleaning process. Dirty water from the containers being cleaned spattered in the direction of previously sanitized utensils and containers.
Further, 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 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.
The issues and violations cited in this letter are not intended to be an all inclusive list of violations that exist at your facility. You are reminded that it is your responsibility for ensuring that your firm operates in compliance with the Act and regulations for Food Labeling (21 CFR Part 101), current Good Manufacturing Practices (21 CFR Part 110) and all other applicable laws and regulations. You should take prompt action to correct these violations and to implement procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice, including seizure and injunction.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations cited above. You should include in your response documentation such as documents and/or procedures implemented, copies of labels for the products that your firm manufactures and distributes, or other information that would assist us in evaluating your corrections. If you can not complete all corrections before you respond, this agency expects that you will explain the reason for your delay and state when you will correct any remaining violations.
Your written reply to these concerns should be directed to the Food and Drug Administration, attention: Ms. Maridalia Torres, District Director, at 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding any issue in this letter, please contact Ms. Marilyn Santiago, Compliance Officer, at (787) 474-9535.
San Juan District