As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Juicer Connections Inc.
Los Angeles, CA
A company in California is on notice from the FDA for serious violations of the Hazard Analysis and Critical Control Point (HACCP) and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation, as well as misbranding violations.
In an April 11, 2023, warning letter, the FDA described an Oct. 24 through Nov. 25, 2022, inspection of Juicer Connections, Inc.’s facility in Los Angeles, CA.
The FDA’s inspection revealed that the firm was not in compliance with FDA regulations and resulted in the issuance of an FDA Form 483.
Some of the significant violations are as follows:
Hazard Analysis and Critical Control Point (HACCP):
1. The firm did not fully implement the monitoring, verification and recordkeeping procedures listed in their HACCP plan.
2. The firm did not validate their HACCP plan is adequate to control food hazards at least once within 12 months after implementation.
3. The firm must monitor the conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with the current good manufacturing practice requirements, that are both appropriate to their plant and the food being processed. However, they failed to monitor the conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with CGMPs in the following areas:
a) On Oct. 26, 2022, they failed to monitor handwashing with sufficient frequency to ensure that hands are washed thoroughly at any time when the hands may have become soiled or contaminated. This is related to prevention of cross contamination from insanitary objects to food.
b) On Oct. 26, 2022, they failed to monitor all plant equipment used in manufacturing, processing, packing, or holding food to ensure it was adequately maintained to protect against contamination. This is related to prevention of cross contamination from insanitary objects to food. The hose installed above the fruit washing tank was observed to be leaking and dripping water directly into the fruit washing tank during production when washing watermelons. The hose was also observed to have a buildup of debris. Their employee stated that this hose is also used for the water ingredient in the reconstitution of juice concentrates.
c) On Oct. 26, 2022, they failed to monitor plumbing with sufficient frequency to ensure that it was adequately maintained to provide adequate floor drainage. This is related to prevention of cross contamination from insanitary objects to food. The only floor drain in their production room was observed to be clogged, and standing water was observed under and around the fruit cutting table during production.
d) On Oct. 26, 2022, they failed to monitor for the presence of pests in the food plant with sufficient frequency to ensure that pests are not allowed in any area. This is related to the exclusion of pests from the food plant. Multiple fly-like insects were observed in the production room during production.
e) On Oct. 26, 2022, they failed to monitor the conditions and practices during processing with sufficient frequency to ensure that cleaning and sanitizing of utensils and equipment was conducted in a manner that protected against contamination of food, food-contact surfaces, or food-packaging materials. This is related to prevention of cross contamination.
i) While an employee was observed using a hose to spray the bottling machine, subsequent splashing was observed going onto the table with exposed gallon bottles staged for filling. Subsequently, the same bottles were filled with watermelon juice. The bottles were not washed or rinsed prior to being filled.
ii) The firm’s employees used (redacted) (as measured by our FDA-issued test strips) to pre-rinse the food contact surfaces of their fruit bath tank, fruit grinder/blender, production utensils, and bottle filling machine. They did not conduct a water rinse or allow the (redacted) to air dry on food contact surfaces prior to use; after the pre-rinse with (redacted), they immediately proceeded to use the aforementioned equipment to manufacture watermelon juice.
f) On Oct. 24, 2022, they failed to monitor the conditions and practices during processing with sufficient frequency to ensure that drip or condensate from fixtures, ducts and pipes does not contaminate food. This is related to the safety of water that comes into contact with food. Ice buildup was observed in the freezer on both the ceiling and floor. Drip condensate was observed dripping from the freezer ceiling onto a bucket of fruit punch concentrate with a broken lid.
1. The firm’s “The Juice Connection Liquid Gold Watermelon Juice 16 oz. and 128 oz.” and “The Juice Connection Liquid Gold Carrot Juice 16 oz.” products are misbranded in that they are false and misleading because the vignette depicts many fruits and vegetables, most of which are not ingredients in or present as flavors in these products. For example, the product labels use a graphic that depicts lemon, lime, orange, kiwi, tomato, artichoke, pineapple, mango, banana, green onions, grapes and possibly star fruit but the only watermelon or carrot juice is used in their production.
2. The firm’s “The Juice Connection Liquid Gold Watermelon Juice 16 oz. and 128 oz.” and “The Juice Connection Liquid Gold Carrot Juice 16 oz.” are misbranded in that they purport to be pasteurized products because the labels bear the statement “pasteurized for your safety.” However, these foods have not been subjected to a safe process or treatment that is prescribed as pasteurization for such food in a regulation nor have they submitted a notification to the Secretary, including effectiveness data regarding the process or treatment as required by that section. Specifically, these juices are not pasteurized, but are instead subject to high pressure processing (HPP).
3. The firm’s “The Juice Connection Liquid Gold Watermelon 16 oz, and 128 oz,” “The Juice Connection Liquid Gold Carrot 16 oz,” “Simply Wholesome Watermelon 16 oz,” and “Simply Wholesome Carrot 16 oz” products are misbranded in that the products are fabricated from two or more ingredients and each ingredient is not declared on the label by its common or usual name and they purport to be beverages containing vegetable or fruit juice but fail to bear a percentage.
4. The firm’s “The Juice Connection Liquid Gold Watermelon 16 oz, and 128 oz.,” “The Juice Connection Liquid Gold Carrot 16 oz,” “Simply Wholesome Watermelon 16 oz.,” and “Simply Wholesome Carrot 16 oz.” products are misbranded in that the nutrition facts information is not provided in accordance with regulation.
5. The firm’s “The Juice Connection Liquid Gold Carrot Juice 16 oz.,” “Simply Wholesome Watermelon 16 oz.,” and “Simply Wholesome Carrot 16 oz” products are misbranded in that the product labels fail to bear the common or usual name of the food.
6. The firm’s “The Juice Connection Liquid Gold Watermelon 16 oz, and 128 oz.” and “The Juice Connection Liquid Gold Carrot 16 oz” products are misbranded in that the product labels fail to include the place of business of the manufacturer, packer or distributor. Specifically, the products list the name of the firm and the telephone contact information but fails to include the street address, city, State, and ZIP code; however, the street address may be omitted if it is shown in a current city directory or telephone directory.
- The labels fail to provide the net quantity of contents statement in terms of fluid measure which is required if the food is liquid. Instead, the labels provide this declaration in terms of weight (oz.). In the case of liquid measure, declaration of the net quantity of contents is to be in the largest whole units (quarts, quarts and pints, or pints, as appropriate) with any remainder in terms of fluid ounces or common or decimal fractions of the pint or quart.
- If ascorbic acid or citric acid are used as preservatives, they must be declared in the ingredient list stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative,” “to retard spoilage,” “a mold inhibitor,” “to help protect flavor,” or “to promote color retention.”
- The name and address of the responsible firm is not declared on the information panel on the Simply Wholesome Carrot 16 oz and the Simply Wholesome Watermelon 16 oz labels. If there is insufficient space on the information panel for all required information, the Nutrition Facts label can move to any alternate panel.
FDA inspection found that the firm has one HACCP plan for all the juice products they process titled “HACCP Plan for Ready to Drink Refrigerated High Pressure Processed (HPP) Apple and Fruit Juices from Concentrates and Fresh Fruit Products” with “Date: June 24, 2019”. However, the HACCP plan does not list and is not specific to each type of juice they process. The plan may only group types of juice products together, or group types of production methods together, if the food hazards, critical control points, critical limits and procedures required to be identified and performed are essentially identical, provided that any required features of the plan that are unique to a specific product or method are clearly delineated in the plan and are observed in practice.
The full warning letter can be viewed here.
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