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WARNING LETTER

WL 648714

Dear Mr. Redwood:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, located at 1920 McGarry St., Vernon, CA 90058-1030 from October 24, 2022, through November 25, 2022. During this inspection the FDA investigators found serious violations of Title 21, Code of Federal Regulations, Part 120 [21 CFR Part 120] Hazard Analysis and Critical Control Point (HACCP) Systems and 21 CFR Part 117 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP & PC rule). At the conclusion of the inspection, FDA issued FDA Form 483, Inspectional Observations, listing the deviations found at your firm. Based upon FDA’s inspectional findings, we determined that your food products are 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 whereby they may have been rendered injurious to heath. Additionally, during the inspection, we conducted label reviews of the following products: The Juice Connection Liquid Gold Watermelon 16 oz. and 128 oz., Simply Wholesome Watermelon 16 oz., The Juice Connection Liquid Gold Carrot 16 oz., and Simply Wholesome Carrot 16 oz. Our review found violations of the label regulations for foods, 21 CFR Part 101. The violations cause your products to be misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], 403(h)(3) of the Act [21 U.S.C. § 343(a)(1)], 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], 403(q) of the Act [21 U.S.C. § 343(q)], 403(i)(1) of the Act [21 U.S.C. §343(i)(1)], and 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)]. You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.

We have reviewed your response received on December 20, 2022. In your response you stated you have hired a consultant, had employees re-trained in HACCP, and are working on a validated process for all juice products your firm manufactures and distributes. Your response included an employee HACCP training invoice, a consultant contract and invoice, and an invoice for a validation study. Your response also stated that you have purchased a metal detector and new pH meter and have installed a new cooler monitoring device. We are unable to further evaluate your response since it did not provide any supporting documentation showing implementation of your HACCP plan and sanitation monitoring based upon corrective actions made. No supporting documentation was provided to show what progress had been made with your consultants. We have concerns regarding the following serious violations outlined below.

Hazard Analysis and Critical Control Point (HACCP) Systems (21 CFR 120):

1. You did not fully implement the monitoring, verification and recordkeeping procedures listed in your HACCP plan, as required by 21 CFR 120.8(a).

Specifically,

Your Critical Control Point (CCP) procedures 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”, identifies monitoring, verification, and recordkeeping procedures, which you did not fully implement, as evidenced by the following:

a) “Mixing All Ingredients in Tank (b)(4)” – Your procedures identify that this CCP controls for the Hazard of “Clostridium botulinum spore present in tank”, with “Critical limits of the Preventive Measures” to be “pH of the juice products below (b)(4)”. For your low-acid juices of Watermelon Juice and Carrot Juice, you (b)(4). You did not implement your monitoring, verification and recordkeeping procedures as detailed below:

i. Monitoring – Your “Monitoring” procedures for this CCP state to “Check pH of the batch” by a “pH meter” with the frequency of “(b)(4)”. From 8/8/2022 through 9/28/2022, you did not document monitoring of the pH for (b)(4) juices manufactured during this timeframe, as required by your HACCP plan and 21 CFR 120.12(a)(4)(i).
ii. Verification – Your “Verification” procedures for this CCP state to conduct verification for the following:

• (b)(4) Verification of the production records for pH of the finished product and corrective action records”. From 8/8/2022 through 9/28/2022, you did not conduct the (b)(4) verification of your production records, as required by your HACCP plan and 21 CFR 120.11(a)(1)(iv)(A).
• “Calibration of pH meters and buffer solutions expiration dates – (b)(4)” – You did not document the verification/calibration of the pH meter with buffers for the juice production during this timeframe, as required by your HACCP plan and 21 CFR 120.11.

Additionally, the instruction manual from the manufacturer of pH meter, states that the pH meter “(b)(4)”. The manufacturer’s instruction manual also states to use buffers of (b)(4) and (b)(4) for calibration. Your Verification procedures provide for using buffers of (b)(4) and (b)(4) to calibrate your pH meter.

iii. Recordkeeping – Your CCP procedures state for monitoring and verification to be documented on “(b)(4)” and “(b)(4)”. On 11/8/2022, our investigator reviewed the two aforementioned records from 8/8/2022 through 9/28/2022, in which it was revealed that all records were missing monitoring and verification documentation, only the “Date”, “Product” name, and “Product Code/Lot Number” were documented; the “pH buffer (b)(4) check expiration”, “pH (b)(4) buffer checked”, “pH (b)(4) buffer checked”, “pH meter calibrated”, “Finished Product pH (b)(4)”, “Product Brix (b)(4) Per Product chart”, “Product meets Critical Limit”, “Signature/Initial”, “Reviewed by and Date” were all left blank. On 11/10/2022, you provided records of manufacture dates, product names, pH values, and Brix values for juices manufactured from 8/1/2022 to 9/28/2022. The information you provided was written on notebook paper that you stated was taken home by your production employee.

The following samples were collected for two types of blended juices with low-acid ingredients manufactured by your facility; you manufacture other blended juices with low-acid ingredients not collected as FDA samples. Based on your production records, these juices were acidified by your facility and achieved pH values below (b)(4). However, these samples revealed that the pH values listed on your monitoring records were incorrect and you were not achieving pH levels below (b)(4), as evidenced by:

iv. FDA Sample 1189046 collected on 11/8/2022 of your finished product Watermelon Juice Pints, 16 fl. oz., under Lot # “(39)1026-1027 USE BY 12/15/2022”, yielded pH values ranging from (b)(4). Your monitoring record for this lot lists pH values of (b)(4) and (b)(4).
v. FDA Sample 1189047 collected on 11/8/2022 of your finished product Watermelon Juice Gallons, 128 fl. oz., under Lot # “(39)1102-1103 USE BY 12/22/2022”, yielded the pH value of (b)(4). Your monitoring record for this lot lists a pH value of (b)(4).
vi. FDA Sample 1189048 collected on 11/8/2022 of your finished product Carrot Juice Pints, 16 fl. oz., under Lot # “(10)1107-1110 USE BY 12/29/2022”, yielded pH values ranging from (b)(4). Your monitoring record for this lot lists pH values of (b)(4) and (b)(4).

b) “High Pressure Process at Contracted Wilmington Facility Document Reviewed CCP#9” identifies that this CCP controls for the Hazard of “Bacterial pathogenic growth”, with “Critical limits of the Preventive Measures” to be “(b)(4) reduction done by High Pressure Process of (b)(4) psi minimum for a dwell time of (b)(4) seconds (See Validation study done by private lab)”. You did not implement your monitoring procedures as evidenced by:

i. Monitoring – Your “Monitoring” procedures for this CCP require a visual review of the “HPP treatment report” with the frequency of “(b)(4)”. However, you did not conduct monitoring prior to distribution to your customers for the following two lots of juices you manufactured and that were processed via high pressure processing (HPP):

• Watermelon Juice Gallons, 128 fl. oz., under Lot # “(39)1102-1103 USE BY 12/22/2022”. This juice was manufactured on 11/2/2022 and processed via HPP on 11/3/2022. You distributed the finished product juice to your customer on 11/7/2022 without first receiving and reviewing the HPP treatment report from your contacted HPP processor. On 11/8/2022, our investigator requested the HPP report for this lot of juice, which you stated was not available for review yet.
• Carrot Juice Pints, 16 fl. oz., under Lot # “(10)1107-1110 USE BY 12/29/2022”. This juice was manufactured on 11/7/2022 and processed via HPP on 11/10/2022. You distributed the finished product juice to your customer on 11/16/2022 without first receiving and reviewing the HPP treatment report from your contacted HPP processor. On 11/17/2022, our investigator requested the HPP report for this lot of juice, which you stated was not available for review yet.

c) “Filtering with mesh and inspection for Metal Detection CCP#(b)(4)” – Your procedures identify that this CCP controls for the “Hazard” of “Metal Fragments”, with “Critical limits of the Preventive Measures” of “Mesh inspection (for damage and holes in the mesh larger than (b)(4) to allow metal fragments into the product”. You did not implement your monitoring, verification and recordkeeping procedures as evidenced by:

i. Monitoring – Your “Monitoring” procedures for this CCP states to conduct a “Mesh Inspection for damage or holes in the mesh” by “Visual Inspection”, with the frequency of “(b)(4) during production days (b)(4)”. You do not conduct and document such monitoring, as required by your HACCP plan and 21 CFR 120.12(a)(4)(i).
ii. Verification – Your “Verification” procedures for this CCP states to conduct “(b)(4) verification Mesh Inspection log”. You do not conduct and document monitoring on such record, thus you do you do not conduct (b)(4) verification, as required by your HACCP plan and 21 CFR 120.11(a)(1)(iv)(A).

2. You did not validate your HACCP plan is adequate to control food hazards at least once within 12 months after implementation, as required by 21 CFR 120.11(b).

Specifically,

Your HACCP Plan for “Ready to Drink Refrigerated High Pressure Processed (HPP) Apple and Fruit Juices from Concentrates and Fresh Fruit Products” is used for all of your fruit and vegetable juice products and lists critical limits of (b)(4) psi/(b)(4) seconds as the control to achieve a 5-log reduction.

Your (b)(4) validation for high pressure processing (HPP), titled “HPP Process Validation in Juice Products (Total Plate Count, E. coli and Listeria monocytogenes) Date: 11/14/2016”, covers the following 5 juice products you manufacture: watermelon juice, Garden Green, Cleanse Health, mango juice, and cranberry Juice. This validation did not assess the efficacy of the HPP process throughout the 50-day shelf life of the products to ensure a minimum 5-log reduction in the pertinent microorganism throughout its shelf life when stored under normal and moderate abuse conditions, as required by 21 CFR 120.24(a).

Additionally, this validation study does not include the other single-strength juice products you manufacture, including, but not limited to, apple juice, beet juice, blood orange, carrot juice, coconut juice, grapefruit juice, lemon juice, lime juice, orange juice, pineapple juice, pomegranate juice, and tangerine juice.

3. You must monitor the conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with the current good manufacturing practice requirements in 21 CFR 117, Subpart B (CGMPs), that are both appropriate to your plant and the food being processed, to comply with 21 CFR 120.6(b). However, you 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 October 26, 2022, you 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, as required by 21 CFR 117.10(b)(3). This is related to prevention of cross contamination from insanitary objects to food, 21 CFR 120.6(a)(3).

i. A production employee was observed washing watermelon fruit (grabbing unwashed watermelon from the bin, dunking it in the bath, and placing it on the cutting table) and cutting off the rinds of the watermelon, for watermelon juice production. The employee did not wash/sanitize hands nor change gloves between these two activities.
ii. An employee filling gallon bottles of watermelon juice with the bottle filler machine halted filling the bottles to pick up the top cover of the machine which was in contact with the wet production floor and placed it on the bottle filler machine using the same gloved hands. The interior of this top cover is a food contact surface. This employee returned to filling bottles with watermelon juice using the same gloved hands without washing and sanitizing his hands. This employee used the same gloved hand to grab and load bottles on the filler machine, which involved inserting a gloved finger into the interior contact surface of the bottle and the bottle lids. The bottles and lids were not washed prior to filling.
iii. During pre-production operations, an employee was observed using gloved hands to unclog the floor drain. This employee was then observed changing gloves but not washing and sanitizing hands prior to filling the fruit washing tank used for washing watermelon fruit prior to cutting.

b) On October 26, 2022, you failed to monitor all plant equipment used in manufacturing, processing, packing, or holding food to ensure it was adequately maintained to protect against contamination as required by 21 CFR 117.40(a)(1). This is related to prevention of cross contamination from insanitary objects to food, 21 CFR 120.6(a)(3). 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. Your employee stated that this hose is also used for the water ingredient in the reconstitution of juice concentrates.

c) On October 26, 2022, you failed to monitor plumbing with sufficient frequency to ensure that it was adequately maintained to provide adequate floor drainage as required by 21 CFR 117.37(b)(4). This is related to prevention of cross contamination from insanitary objects to food, 21 CFR 120.6(a)(3). The only floor drain in your production room was observed to be clogged, and standing water was observed under and around the fruit cutting table during production.

d) On October 26, 2022, you 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, as required by 21 CFR § 117.35(C). This is related to the exclusion of pests from the food plant, 21 CFR § 120.6 (a)(8). Multiple fly-like insects were observed in the production room during production.

e) On October 26, 2022, you 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, as required by 21 CFR 117.35(a). This is related to prevention of cross contamination, 21 CFR 123.6(a)(3).

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) Your employees used (b)(4) (as measured by our FDA-issued test strips) to pre-rinse the food contact surfaces of your fruit bath tank, fruit grinder/blender, production utensils, and bottle filling machine. They did not conduct a water rinse or allow the (b)(4) to air dry on food contact surfaces prior to use; after the pre-rinse with (b)(4), they immediately proceeded to use the aforementioned equipment to manufacture watermelon juice.

f) On October 24, 2022, you 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, as required by 21 CFR 117.20(b)(4). This is related to the safety of water that comes into contact with food, 21 CFR 123.6(a)(1). 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.

Misbranding Violations

1. Your 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 within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] 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. Your The Juice Connection Liquid Gold Watermelon Juice 16 oz. and 128 oz. and The Juice Connection Liquid Gold Carrot Juice 16 oz. are misbranded within the meaning of section 403(h)(3) of the Act [21 U.S.C. § 343(h)(3)] 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 you 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. Your 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 within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] 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, as required by 21 CFR 101.4 and 101.30 (respectively). For example:

a) The ingredient statement for your The Juice Connection Liquid Gold Watermelon 16 oz, and 128 oz. and Simply Wholesome Watermelon 16 oz. fail to declare the ingredient citric acid.

b) The Simply Wholesome Watermelon 16 oz, and Simply Wholesome Carrot 16 oz labels do not bear any ingredient declarations.

c) The Juice Connection Liquid Gold Carrot Juice 16 oz, label does not declare concentrated carrot juice by its common or usual name. “Carrot (Con.)” is the not the common or usual name for this ingredient. 21 CFR 101.4(a)(1).

d) All of the products purport to be beverages containing fruit juice and/or vegetable juice, but the labels fail to bear a percentage (the total percentage of such fruit or vegetable juice contained in the food consistent with the language in section 403(i)(2) of the Act) declared by the words "Contains_ percent (or %)_ juice" or a similar phrase with the first blank filled in with the percentage of the juice and the second blank (if used) filled in with the name of the particular fruit or vegetable (e.g., "Contains 50 percent apple juice" or "50 percent juice") juice, as required by 21 CFR 101.30(b)(1).

4. Your 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 within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not provided in accordance with 21 CFR 101.9. Specifically,

a) For your Simply Wholesome Watermelon 16 oz. and Simply Wholesome Carrot 16 oz. products:

• The serving size is incorrect. The Reference Amount Customarily Consumed (RACC) for juices and fruit drinks is 240 mL [21 CFR 101.12(b), Table 2]. The net quantity of contents is declared as 16 oz. Sixteen fluid ounces is equivalent to 476 mL. Therefore, the products meet the definition of a single serving container under 21 CFR 101.9(b)(6) because the products are packaged and sold individually and contains less than 200 percent of the RACC. Therefore, the serving size would be the entire container. As such, all of the nutrient information is incorrect.
• The dietary fiber and total sugars amounts are not declared in accordance with 21 CFR 101.9(c)(6) on the Simply Wholesome Carrot 16 oz. label because these are declared as 0 despite a Total Carbohydrate declaration of 22 g.
• The saturated fat amount and percent daily value for saturated fat are not declared in accordance with 21 CFR 101.9(c)(2)(i) and 21 CFR 101.9(d)(7) respectively on the Simply Wholesome Watermelon 16 oz. label because it is declared as .36 g with a daily value of 2%. According to the regulations, if the serving contains less than 0.5 gram, the content must be expressed as 0. Furthermore, the percent daily value would also be 0.
• In accordance with 21 CFR 101.9(c)(8)(iii) the quantitative amounts of potassium, calcium and iron must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8)(iv).

5. Your The Juice Connection Liquid Gold Carrot Juice 16 oz., Simply Wholesome Watermelon 16 oz., and Simply Wholesome Carrot 16 oz products are misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product labels fail to bear the common or usual name of the food. For example:

a) The Juice Connection Liquid Gold Carrot Juice 16 oz. and the Simply Wholesome Carrot 16 oz. label fails to bear a name that includes a term indicating the fact that the juices are from concentrate, such as "from concentrate," or "reconstituted" in accordance with 21 CFR 102.33(g)(1).

b) The Simply Wholesome products are labeled as either Carrot or Watermelon. These statements of identity do not meet the requirements of 21 CFR 101.3(b) because they are not appropriately descriptive of products that appear to be beverages or juices.

6. Your The Juice Connection Liquid Gold Watermelon 16 oz, and 128 oz. and The Juice Connection Liquid Gold Carrot 16 oz products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(d). 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.

Label Comments

• The labels fail to provide the net quantity of contents statement in terms of fluid measure which is required if the food is liquid [21 CFR 101.7(a)]. 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 as required by 21 CFR 101.7(j)(1).
• 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” in accordance with 21 CFR 101.22(j).
• 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 (21 CFR 101.2(b)). If there is insufficient space on the information panel for all required information, the Nutrition Facts label can move to any alternate panel [21 CFR 101.9(j)(13)(ii)(C) & (j)(17)],
• In regard to the level of significance for the declaration of potassium, calcium, and iron, please see the additional explanation in “Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals: Guidance for Industry” found at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-nutrition-and-supplement-facts-labels-questions-and-answers-related-compliance.

HACCP Comment

Our inspection found that you have one HACCP plan for all the juice products you 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 you process, as required. Please be advised that 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.

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written response should be directed to:

Sergio Chavez, Director Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612

or emailed to [email protected].

Refer to the Unique Identification Number CMS 648714 when replying.

If you have questions regarding this letter, please contact Rochelle R. Blair, Compliance Officer at [email protected], or (949) 608-4496.

Sincerely,
/S/

Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations- West Division 5

cc: Benson Yee
Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, California 95899-7435