| Public Health Service Food and Drug Administration |
| 466 Fernandez Juncos Avenue San Juan, Puerto Rico, 00901 Compliance Branch Telephone: 787-474-9500 FAX: 787-729-6658 |
Department of Health and Human ServicesWARNING LETTER
11-SJN-WL-07
March 23, 2011
VIA OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
Mr. Bartolo Pérez Román
President
Jonlly Fruits, Inc.
HC-67 Box 13040
Bayamón, P.R. 00956
Dear Mr. Pérez Román:
From September 20 to October 5, 2010, the U.S. Food and Drug Administration (FDA) inspected your fruit juice and fruit juice beverage processing facility, located at Road 831, kilometer 2.7, Sector Minillas, Bayamón, Puerto Rico 00956. Our investigators documented serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR Part 120). In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with §§ 120.6, 120.7, and 120.8 or otherwise operate in accordance with the requirements of Part 120, renders the juice products 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)). Accordingly, your orange juice concentrate is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. The inspection also found repeat serious violations of the Current Good Manufacturing Practice (CGMP) regulation for food manufacturers, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110).
During the inspection of your facility, product labels for your fruit juices and fruit juice beverages were collected. We have reviewed your product labels and find that your labels cause your products to be misbranded within the meaning of section 403 of the Act (21 U.S.C. § 343).
You may find the Act, the Current Good Manufacturing Practice (CGMP) regulation for food manufacturers, the juice HACCP regulation, the Food Labeling regulations, and the juice HACCP Regulation through links in FDA's home page at http://www.fda.gov/.
The FDA investigators presented you with a Form 483 on October 5, 2010. Your significant violations were as follow:
1. After completing a written hazard analysis required by 21 CFR 120.7, you must have a written HACCP plan that outlines the necessary controls, when such analysis reveals one or more food hazards that are reasonably likely to occur during processing, to comply with 21 CFR 120.8(a). However, you failed to develop the required HACCP plan for your orange juice concentrate.
During previous inspections you expressed that your understanding was that your firm was not required to comply with 21 CFR Part 120 Hazard Analysis and Critical Control Point System since it was a function of your supplier of frozen orange juice concentrate.
However, the term "Juice" means the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree (21 CFR 120.1).
Further, the juice HACCP regulation requires that processors apply HACCP principles if they make juice or juice concentrates for subsequent beverage use (see 21 CFR 120.1(a), 21 CFR 120.8). The FDA has clarified in guidance that “juice or juice concentrates” in this context means 100 percent juice under 21 CFR 101.301 The guidance also states that for beverages containing less than 100 percent juice, only the juice ingredient needs to be made applying HACCP principles.2
Your firm (b)(4). The 21 CFR 101.30 establishes that (b)(4) required to determine a 100% orange juice. Therefore, your juice is subject to the regulatory requirements in 21 CFR Part 120.
Further, your facility is a final juice processor and packaging site and, consequently, you are required by 21 CFR Part 120, Hazard Analysis and Critical Control Point System (HACCP) to comply with the 5 log reduction process (see 21 CFR 120.24).
During the inspection, the FDA investigators also observed violations from 21 CFR Part 110 Current Good Manufacturing Practice in Manufacturing, Packaging, or Holding Human Food. Your CGMP violations are as follows:
2. Your firm did not protect food from adulteration with lubricants, fuel, metal fragments, contaminated water, or any other contaminants (see 21 CFR 110.40(a)). Specifically:
• The (b)(4) mixing tanks located in the production room did not have protective covers. On September 20, 2010, water drops from the outer surface of a pipeline that runs above the exposed tanks were observed to be dripping into one of the tanks filled with orange juice drink. The pipeline was observed to be not clean. This condition may result in the cross contamination of the in-process ready-to-drink juice beverage.
• On September 21, 2010, the knob of a water valve fell inside a mixing tank filled with product water. An employee removed the knob from the tank with his hands, reaching into the tank with bare arms. From our investigators’ observations of his actions, the employee intended to continue the processing by adding juice ingredients to the water. At that point, your firm’s Food Consultant stopped the employee and asked him to drain the product water and to wash and sanitize the tank before use again.
3. Your firm failed to maintain adequate sanitary facilities and accommodations (see 21 CFR 110.37(a)). Specifically, you did not provide running water at a suitable temperature and under suitable pressure for employee sanitary facilities. The hand washing sink of the toilet rooms located outside the processing area on the second floor was not equipped with hot water and did not have enough water pressure to remove soil and soap.
4. Your firm did not ensure that all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conformed with hygienic practices to the extent necessary to protect against contamination of food (see 21 CFR 110.10(b)). Specifically, on September 21, 2010, employees were observed changing operations from cleaning equipment to measuring and adding ingredients into the mixing tank without first washing their hands (see 21 CFR 110.10(b)(3)) or changing their gloves (see 21 CFR 110.10(b)(5)).
5. Your firm failed to clean all food-contact surfaces, including utensils and food-contact surfaces of equipment, as frequently as necessary to protect against contamination of food (see 21 CFR 110.37(d)).
Specifically, on September 21, 2010, your firm failed to ensure that the storage tanks and the filling machine were adequately cleaned when there was a change in product. For example:
• One of the storage silo tanks was washed after a batch of fruit punch was bottled. When the tank was opened for inspection, there were residues of fruit punch on the bottom of the tank, demonstrating that the cleaning operation was not effective.
• The filling machine was washed after a batch of grape fruit beverage was bottled. A batch of a different juice beverage was scheduled to be transferred to the filling machine. Inspection of this filling machine found grape juice condensate residues dripping from the lid of the filling machine tank into the filling bowl.
• The mechanical washer used to wash and sanitize shipping baskets, which hold containers of packed fruit juice beverages, was out-of-service. On September 28, 2010, the basket washing operator used only running water from a hose to clean baskets. FDA investigators observed dirt encrustation on the baskets after washing. These unclean baskets were later transferred for use in the packing room located on the second floor.
6. Your firm failed to properly identify, hold, and store toxic cleaning compounds and sanitizing agents in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials (see 21 CFR 110.37(b)(2)).
Specifically, your firm failed to identify working containers used to hold sanitizing agents such as chlorine. On September 21, 2010, a 5-gallon plastic pail without any identification was used to hold the chlorine mix used to sanitize processing equipment in the production room. In addition, a food employee was observed using a spray container labeled "(b)(4)" (a household degreasing product, not chlorine sanitizer) to apply the chlorine sanitizer to the mixing tanks.
7. You must store foods which can support the rapid growth of undesirable microorganisms at a temperature that prevents the food from becoming adulterated, to comply with 21 CFR 110.80(b)(3)(i). However, on September 28, 2010 fruit juice concentrates in metal drums and fruit juice bases in plastic pails were stored in a freezer which was observed to have an ambient temperature of (b)(4). The labels of the fruit juice concentrates state that the product must be stored at a temperature of - 18° C (0° F), and the fruit juice bases at a temperature between 38 and 45° F.
In addition, refrigerated fruit juice beverages, which should be stored at 45°F or below, were recorded or observed to be held in a cooler on the following dates at the following ambient temperatures:
DATE TEMPERATURE
(b)(4)
We acknowledge the adjustments that you stated were made to the freezer and refrigerator during the inspection, however that did not completely address the violation. For example, the investigators noted problems with the frequency of temperature measurements, your thawing procedures, a broken freezer door, and missing plastic flaps over freezer doors.
8. Your firm failed to maintain buildings and physical facilities in repair sufficient to prevent food from becoming adulterated, to comply with 21 CFR 110.35(a).
Specifically, on September 20, 2010, FDA investigators observed rain water entering the building from windows and the cargo loading door located at the East side wall of the second floor of the building. Water leaks were also observed through the ceiling and through an electrical wire introduced from the outside through the East side wall. Rain water was observed running across the floor and wetting wooden pallets that held plastic juice beverage containers and paper bags of raw materials such as sugar, sesame seeds, and tree bark leaves used to process "mavi" beverage. A heavy current of rain water was also observed entering from the back of the building and running across the floor to the area where plastic shipping baskets are washed. This area also connects directly to the cooler where finished products are stored. Additionally, the door that separates the cooler from the baskets washing area was open and broken. This broken door provides access for the entry of pests from the outside of the building into the cooler area.
9. Your firm failed to properly store equipment and remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures, to comply with 21 CFR 110.20(a)(1).
Specifically, FDA investigators observed broken wooden pallets, empty plastic containers, plastic bags, old pieces of equipment, out of service trucks and cars, pieces of plastic pipes, trash, metal drums and lids, and other litter in the parking lot in front of the receiving and delivery platform of the manufacturing plant. Trash and unused equipment were also observed close to the potable water tanks and at the back of the building.
We acknowledge that, although some corrections were made during the inspection, not all of the trash and unused equipment were removed.
10. Your firm failed to transport finished food under conditions that would protect against physical and microbial contamination, to comply with 21 CFR 110.93.
Specifically, the refrigerated truck with license number (b)(4) used to transport finished fruit beverages is not maintained in a clean or good state of repair. Old dirt encrustations were observed between the rails of the floor. In addition, the bottom side of the doors and the wall at the front of the cargo area were observed to be broken and with the insulating material exposed. These conditions do not allow adequate cleaning of the storage cabin of the transportation vehicle.
In addition, with regard to your orange juice concentrate product, you failed to comply with 21 CFR 120.6(b) because you failed to monitor conditions and practices during processing with sufficient frequency to ensure conformance with those conditions and practices specified in 21 CFR Part 110 that are appropriate both to the plant and the food being processed.
Labeling Violations:
1. Your Jonlly Light China, Jonlly Light Fruit Punch, Jonlly Light Toronja, Jonlly Light Parcha, Jonlly Light Acerola, (b)(4) Fruit Punch Light, (b)(4) Acerola Light, (b)(4) Guava Piña Light, (b)(4) Parcha Light and (b)(4) China Light are misbranded within the meaning of section 403(r)(1)(A) of the Act (21 U.S.C. § 343(r)(1)(A)) because the product labels bear a nutrient content claim but do not meet the requirements to make the claim. Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation promulgated by the Secretary (or by delegation, FDA) authorizing the use of such a claim. Characterizing the level of a nutrient in food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act. Specifically:
• The product labels declare the claim “Light,” but fail to meet the requirements for making the claim because the product labels do not declare a reference food as specified under 21 CFR 101.13(j) and 101.56(b). FDA has defined the term “light” at 21 CFR 101.56. The regulation states, in part, that if the food derives less than 50% of its calories from fat, the calories in a product using the term “light” must be reduced by at least 1/3 per reference amount customarily consumed compared to an appropriate reference food, the identity of the reference food and the percent or fraction that the calories are reduced must be declared in immediate proximity to the most prominent “light” claim, and the label must bear quantitative information comparing the level of calories in the product per labeled serving size with that of the reference food. An appropriate reference for a food making a ‘light’ claim is described in 21 CFR 101.13(j)(1)(ii)(A). Therefore, because your products do not declare a reference food, the use of the term “light” in the labeling misbrands your products.
• Your Jonlly Light China, Jonlly Light Fruit Punch, Jonlly Light Toronja, Jonlly Light Parcha and Jonlly Light Acerola labels declare “100 % Vitamina C” (100 % Vitamin C), which is an incomplete nutrient content claim. The statements fail to describe the percentage of vitamin C in relation to the Reference Daily Intake (RDI) for the vitamin in a serving of the products (21 CFR 101.13(q)(3)). For example, a complete nutrient content claim may read, “100% DV for Vitamin C” or “100% RDI for vitamin C.”
2. Your Jonlly Light, (b)(4) , (b)(4) Light, Natural Tropic and (b)(4) brands of juice products sold to individual customers are misbranded within the meaning of Section 403(i)(1) of the Act (21 U.S.C. § 343(i)(1)) because there is no statement of identity on the Principal Display Panel, as required under 21 CFR 101.3. Specifically,
• The principal display panels of your (b)(4) and (b)(4) Light labels have the name of the particular fruit used in the product; however they do not bear a statement of the identity for the product.
• The principal display panels of your (b)(4) , Jonlly Light and Natural Tropic labels contain a picture of a fruit that bears a resemblance to an orange and the name of the particular fruit however they do not bear a statement of the identity for the product.
3. Your Jonlly Light, (b)(4) , (b)(4) Light, Natural Tropic and (b)(4) brands of juice products are further misbranded within the meaning of section 403(i)(2) of the Act (21 U.S.C. § 343(i)(2)) because the declared percent juice statement, “____% Jugo Natural (___% Natural Juice)” (where the blank is the percentage of juice declared on the product label) is not declared on the information panel in a manner that is consistent with the requirements of 21 CFR 101.30(b)(1).
For additional information on General Food Labeling requirements go to http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/default.htm.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, and all application regulations, including the juice HACCP regulation (21 CFR Part 120), the Current Good Manufacturing Practice regulation (21 CFR Part 110), and food labeling regulations. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Failure to promptly correct these violations may result in regulatory action without further notice, including seizure of violative product(s) and/or injunction against the manufacturers or distributors of violative products.
We also note the following in regard to your product labels:
For your (b)(4) China, (b)(4) Acerola Light, and (b)(4) China Light juice products, the nutrition facts information is not in an appropriate format, as defined in 21 CFR 101.9. Specifically, the Dietary Fiber for your (b)(4) China is over 0.5g, but less than 1g and is not expressed as “Contains less than 1g” OR “less than 1g” (21 CFR 101.9(c)(6)(i)). The (b)(4) Acerola Light and (b)(4) China Light product labels fail to set off the nutrition information in a box by use of hairlines from other mandatory label information (21 CFR 101.9(d)(1)(i)). And the (b)(4) China Light product label fails to round the values for certain nutrients as specified by 21 CFR 101.9(c). For example, your “Calories” figure should be expressed to the nearest 5-calorie increment up to and including 50 calories and in 10 calorie increments above 50 calories (21 CFR 101.9(c)(1)).
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation, such as HACCP and verification records, or 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 violations.
Please send your reply to the Food and Drug Administration, Attention: Carlos I. Medina, Compliance Officer, 466 Fernandez Juncos Avenue, San Juan, Puerto Rico, 00901-3226. If you have questions regarding any issues in this letter, please contact Mr. Medina at 787-474-9539 or at carlosi.medina@fda.hhs.gov.
Sincerely,
/s/
Maridalia Torres
District Director
San Juan District
1 See Guidance for Industry: The Juice HACCP Regulation - Questions Answers, available at http://www.fda.govlFoodiGuidanceComplianceRegulatorylnformation/GuidanceDocuments/Juice/ucm072981.htm (accessed February 21, 2011).
2See id.
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