Inspections, Compliance, Enforcement, and Criminal Investigations
Estrella Food Products, Inc. 3/26/10
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
March 26, 2010
Return Receipt Requested
Mr. Jose Francisco Areizaga
President and Owner
Estrella Food Products, Inc.
Minillas Industrial Park
325 Street D, Suite 2
Bayamon, PR 00959-1906
Dear Mr. Areizaga:
The Food and Drug Administration (FDA) inspected Estrella Food Products, Inc., your food manufacturing facility, located at number 325 Street D, Minillas Industrial Park, Bayamon, Puerto Rico 00959, from October 26 to November 9, 2009. The inspection was conducted to assess your compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and applicable implementing regulations found in Title 21 of the Code of Federal Regulations (21 CFR).
During the inspection our investigator documented serious repeat deviations from the regulations that cause the products manufactured in your facility to be adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] in that they 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.
Further, during the inspection, our investigator collected labels for your food products. Our review of the labels and other evidence collected during the inspection found repeat deviations from the labeling regulations that cause your 'Empanadillas Sabor a Carne' (Meat Flavor Turnovers), 'Empanadillas de Pizza' (Pizza Turnovers), and 'Pastelillos de Queso' (Cheese Turnovers) 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 regulations in the CFR through links in FDA's website at http://www.fda.gov.
1. To comply with 21 CFR 110.80(b)(2), all food manufacturing, including packaging and storage, shall be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or the contamination of food. One way to comply with this requirement is careful monitoring of physical factors, such as time, temperature, and humidity, and manufacturing operations, such as heat processing and refrigeration, to ensure that mechanical breakdowns, time delays, temperature fluctuations, and other factors do not contribute to the decomposition or contamination of food. However, your manufacturing processes and storage conditions and controls are not adequate to minimize the risk of contamination with undesirable microorganisms, particularly those of public health significance. For example, Salmonella and E. coli are a health concern in products containing poultry and meat ingredients, but your firm did not conduct food manufacturing under such conditions and controls to minimize the potential for the growth of these microorganisms. Specifically:
a. During the inspection the temperature in your refrigeration cooler unit was taken with an FDA-Calibrated temperature reading device. The temperature read was 70' F, which is substantially higher than the recommended cold storage temperature. In order to maintain the safety of foods that can support the rapid growth of undesirable microorganisms, refrigerated food must be maintained at 45' F or below as appropriate for the particular food.
b. During the inspection the temperatures in your freezer units read as follows: (b)(4) and (b)(4). In order to maintain the safety of foods that can support the rapid growth of undesirable microorganisms, frozen food must be maintained in a frozen state. The recorded freezer temperatures at your facility were not adequate to ensure that the food stored in the freezer would be maintained in this state.
c. During the cooking, cooling, and storage of the mixtures used to stuff the 'Pastelillos Sabor PolIo' (Chicken Flavor Turnovers), 'Empanadillas Sabor a Came' (Meat Flavor Turnovers), and 'Pastelillos Sabor Came' (Beef Flavor Turnovers), your firm did not monitor the temperature and the exposure time of the mixture. FDA suggests that your firm conduct careful monitoring of physical factors, such as exposure time and temperature, throughout the manufacturing process to ensure that the mixtures are cooked at a temperature and for a time sufficient to inactivate microorganisms of pathogenic concerns, and that the mixtures are not stored in a manner that would encourage the growth of microorganisms.
2. To comply with 21 CFR 110.10(b), your plant management shall take all reasonable measures and precautions to ensure that all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices to the extent necessary to protect against contamination of food and maintain cleanliness. However, such measures were not taken. Specifically:
a. Your employees did not wear outer garments in a manner to protect against contamination of food, as required by 21 CFR 110.10(b)(1). Your employees wore dirty outer garments with what appeared to be encrusted dough material while carrying dough material directly in contact with their outer garments, and your employees failed to change their outer garments after leaving the production area to receive products on the outside area of the building and returning to the production area.
b. Your employees did not wash and sanitize their hands before starting to work, after each absence from their work station, and after their hands my have become soiled or
contaminated, as required by 21 CFR 110.10(b)(3). Specifically, your employees performed processing and packaging operations with their bare hands and did not wash their hands prior to conducting these operations, including the dough and turnover filling operations.
c. Your employees failed to wear hair restrainer nets in an effective manner and failed to wear facial hair restrainers, as required by 21 CFR 110.10(b)(6).
3. To comply with 21 CFR 110.37, your plant shall be equipped with adequate sanitary facilities and accommodations. However, your plant is not equipped with adequate sanitary facilities and accommodations. Specifically:
a. Your hand washing stations located in the production area and in the women's and men's toilet facilities failed to provide soap, sanitizer, towels, or drying devices, as required by 21 CFR 110.37(e)(2) and (3).
b. Toilet facilities must be maintained in a sanitary condition, as required by 21 CFR 110.37(d)(1). However, both women's and men's toilet facilities lacked toilet paper.
c. You failed to post signs directing your employees to wash and sanitize hands as appropriate, as required by 21 CFR 110.37(e)(5).
4. To comply with 21 CFR 110.35(a), you must clean and sanitize utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. However, you failed to sanitize the utensils used in your manufacturing operation to protect against such contamination. Your cleaning solution is prepared using hot water and dish wash detergent. A dish wash detergent is not an adequate sanitizing agent. Sanitizing agents must adequately treat food-contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer.
Moreover, this solution is used for the cleaning of all utensils and it is neither changed nor temperature monitored during the process. Further, on November 9, 2009, our investigator observed that employees were instructed to rinse the utensils using only water since the dish wash detergent was exhausted. This included the utensils used to prepare the turnover shells with the mixture containing meat or poultry ingredients.
5. To comply with 21 CFR 110.35(c), you must take effective measures to exclude pests from your food processing areas. However, during the inspection our investigator observed:
a. Two birds flying into the processing area through torn screens. These birds rested on the ceiling beams directly above the food processing area where dough and turnover shells were pending to be packed.
b. Flies and mosquitoes flying into and within the plant as well as multiple spider webs in the equipment, storage racks, and the ceiling of the processing area.
1. Your 'Empanadillas Sabor a Carne' (Meat Flavor Turnovers), 'Empanadillas de Pizza' (Pizza Turnovers), and 'Pastelillos de Queso' (Cheese Turnovers) 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. Section 201(qq) of the Act [21 U.S.C. § 321(qq)] defines "major food allergens" as 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:
i. 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
ii. 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 food labels fail to declare the following major food allergens:
• Wheat: Your 'Empanadillas Sabor a Carne' (Meat Flavor Turnovers) and 'Empanadillas de Pizza' (Pizza Turnovers) products contain wheat flour.
• Wheat and milk: Your 'Pastelillos de Queso' (Cheese Turnovers) and 'Empanadillas de Pizza' (Pizza Turnovers) products contain wheat and milk, which are components of flour and imitation cheese.
• Soy: Your 'Empanadillas Sabor a Carne' (Meat Flavor Turnovers) product contains Soy Protein Caramel (Texturized Vegetable Protein Caramel).
Additional information about allergen source labeling is available on our website at http://www.cfan.fda.gov/~dms/wh-alrgy.html.
2. Your 'Empanadillas Sabor a Carne' (Meat Flavor Turnovers), 'Empanadillas de Pizza' (Pizza Turnovers), and 'Pastelillos de Queso' (Cheese Turnovers) products are also 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 product.
Specifically, 21 CFR 101.4(b)(l4), requires that 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 'Empanadillas Sabor a Came' and 'Empanadillas de Pizza' products declare vegetable shortening as an ingredient in the products but fail to list the specific components of that fat ingredient. The term "vegetable shortening," on its own, is not a proper common or usual name because it does not list the common or usual name of each component fat or oil, as required by 21 CFR 10 l.4(b)(14). Your 'Pastelillos de Queso' product declares vegetable oil as an ingredient but fails to list the specific components of that oil ingredient. The term "vegetable oil," on its own, is not a proper common or usual name because it does not list the common or usual name of each component fat or oil, as required by 21 CFR 101.4(b)(14).
3. Your 'Empanadillas de Pizza' and 'Empanadillas Sabor a Came' products are misbranded under section 403(i)(2) of the Act because their ingredient statements fail to list the component ingredients of all of their ingredients, as required by 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 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. Specifically, your 'Empanadillas de Pizza' product contains "imitation mozzarella cheese"; however, the sub-ingredients, namely water, vegetable oil, (refined palm and soy oils), casein, modified starch, salt, milk serum sodium citrate, sorbic acid, guar gum, and annatto, are not declared on the ingredient statement of the finished products. Your 'Empanadillas Sabor a Came' and 'Empanadillas de Pizza' products contain "enriched flour"; however, the sub-ingredients, namely bleached wheat flour, niacin, reduced iron, thiamin mononitrate, riboflavin, enzyme, and folic acid, are not declared on the ingredient statement of the finished products.
4. Your 'Empanadillas de Pizza', 'Empanadillas Sabor a Came', and 'Pastelillos de Queso' products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not in an appropriate format, as required by 21 CFR 101.9.
• The labels for your 'Empanadillas de Pizza' (12 and 24 unit) and 'Empanadillas Sabor a Came' (12 and 24 unit) products fail to declare the amount of trans fat as required by 21 CFR 101.9(c)(2)(ii).
• The labels for your 'Empanadillas de Pizza', 'Empanadillas Sabor a Carne', and 'Pastelillos de Queso' products fail to properly declare the serving sizes as required by 21 CFR 101.9(b) and 101.12(b). Specifically, serving sizes are determined based on the Reference Amounts Customarily Consumed (RACC), which are provided by 21 CFR 101.12(b). The 'Empanadillas de Pizza' and 'Empanadillas Sabor a Came' product labels declare the serving size as "1 piece (3.5 ounces) (99g)", and the 'Pastelillos de Queso' product label declares the serving size as "1 piece (45 g)." However, the RACC for "Mixed dishes not measurable with a cup" is "140 g" which is closer to 3 pieces or turnovers. Therefore, the nutrition information is not accurate per serving because it is not based on the established RACC provided for this food product in 21 CFR 101.12(b).
We may take further action if you do not promptly correct these violations. For instance, we may take action to seize your product(s) and/or enjoin your firm from operating.
We offer the following comment concerning the 'Empanadillas de Pizza' and the 'Empanadillas Sabor a Carne' product labels:
• The net weight statement "NET WT. 18 oz./5 Unidades" is not declared in accordance with 21 CFR 101.105(j), which requires that, on packages containing less than 4 pounds or 1 gallon and labeled in terms of weight or fluid measure, but containing more than 1 pound, the net weight statement shall be expressed in ounces, followed in parentheses by a declaration in pounds.
In addition, we offer the following comment concerning the 'Pastelillos de Queso' product label:
• The product label lists "Allergen statement: contains: wheat," which appears to be a typographical error or misspelling.
Furthermore, your product labels contain information in both English and Spanish. We recognize that these products are sold only in Puerto Rico where the predominant language is other than English and therefore the required information may appear only in Spanish [21 CFR 101.15(c)(1)]. However, in accordance with 21 CFR 101.15(c)(2), since the product labels include information in English (another language) as well as Spanish, all required information must also appear in English and Spanish.
Additionally, we have determined that your facility is subject to the registration requirement in section 415 of the Act [21 U.S.C. § 350d], and our implementing regulation at 21 CFR Part 1, Subpart H. During the previous inspection of your facility on December 2008 and during the current inspection you were (or your representative was) advised of this requirement. The failure to register a facility as required is a prohibited act under section 301(dd) of the Act [21 U.S.C. § 331(dd)]. Our records indicate that, to date, this facility has not been registered with FDA.
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility's owner, operator, or agent in charge, register the facility with FDA immediately. Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number. Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537.
This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
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 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 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 email@example.com.
Maridalia Torres Irizarry
San Juan District Office