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  5. Sol-ti Inc. - 653764 - 03/16/2023
  1. Warning Letters

WARNING LETTER

Sol-ti Inc. MARCS-CMS 653764 —

Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Ryne O’Donnell
Recipient Title
CEO
Sol-ti Inc.

8380 Miralani Dr, Ste A
San Diego, CA 92126
United States

Issuing Office:
Division of Human and Animal Food Operations West V

United States

WARNING LETTER

March 16, 2023

WL 653764

Dear Mr. O’Donnell:

The United States Food and Drug Administration (FDA) inspected your facility, located at 8380 Miralani Dr, Ste A, San Diego, CA 92126 from December 19, 2022, through February 8, 2023. We found that you have 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 to have and implement a HACCP plan that complies with the requirements of 21 CFR 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 ready-to-drink (RTD) juice products and juice ingredients are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the juice HACCP regulation, and the Juice HACCP Hazards and Controls Guidance through links in FDA’s home page at www.fda.gov.

We received your response, dated February 28, 2023, concerning the FDA 483. After reviewing the inspectional findings and your response, we are issuing this letter to advise you of FDA’s remaining concerns.

Your significant violations were as follows:

1. Your HACCP plan does not include control measures that will consistently produce a 5-log reduction in the most resistant microorganism of public health significance that is likely to occur in the juice, for a period at least as long as the shelf life of the product, as required by 21 CFR 120.24(a).

Specifically, your HACCP plans for your SuperShot and SuperAde products identify the UV Treatment step as a critical control point (CCP). The UV Treatment CCP has a critical limit of “Each UV lamp displays as ‘Pass.’ There are (b)(4) UV lamps” to control for E. coli O157:H7. However, your UV Treatment process has not been validated to achieve a 5-log reduction of the pertinent microorganisms, such as Cryptosporidium parvum, E. coli O157:H7, and Salmonella, for your SuperShot Crown product, which contains 100% juice with added ingredients, including SuperShot Crown, Lot# 22325.

Additionally, your SuperShot Energy+, SuperAde Chlorophyll Aloe, and SuperAde Blue Spirulina products are beverages containing less than 100% juice. Per 21 CFR 120.1(a), any juice used as an ingredient in beverages shall be processed in accordance with the requirements of the juice HACCP regulation. As such, the critical limit at the UV Treatment CCP of “Each UV lamp displays as ‘Pass.’ There are (b)(4) UV lamps” has also not been validated to achieve a 5-log reduction of the pertinent microorganisms, such as Cryptosporidium parvum, E. coli O157:H7, and Salmonella, for the juice ingredients incorporated into your juice-containing beverages, including SuperShot Energy+, Lot# 22305, SuperAde Chlorophyll Aloe, Lot# 23017, and SuperAde Blue Spirulina, Lot# 23017.

We reviewed your response and determined it is incomplete. In your response, you stated both your UV Process and cleaning process validation studies will be performed by the same third-party company, starting February 24, 2023, and concluding June 30, 2023. In addition, you stated your Food Safety and Quality Leader will complete their HACCP training by March 30, 2023, and afterwards they will revise procedures, forms, and work instructions to ensure conformance to the requirements, and conduct (b)(4) reviews of your HACCP plans. However, you did not provide any evidence indicating corrective actions are in progress, including but not limited to a signed contract with the third-party company confirming your validation studies are underway, or a HACCP training registration confirmation. Further, you did not indicate how you will ensure the safety of your products in the absence of any validated HACCP plans.

2. Your HACCP plan does not list all food hazards that are reasonably likely to occur, as required by 21 CFR 120.8(b)(1).

Specifically, your HACCP plan for your SuperShot products does not identify the following hazards that are reasonably likely to occur:

  • Metal (Grinding)
  • Pathogen growth (Ingredient storage)
  • Colors and additives
  • Heavy metals
  • Clostridium botulinum

Additionally, your HACCP plans for your SuperAde products does not identify the following hazards that are reasonably likely to occur:

  • Metal (Grinding)
  • Pathogen growth (Ingredient storage)

We reviewed your response and determined it is incomplete. In your response, you stated your Food Safety and Quality Leader will complete a HACCP training by March 30, 2023, and afterwards they will review and update your hazard analysis to incorporate all identified hazards and define critical control points by March 20, 2023. You stated you will define measure(s) that can be applied to prevent, reduce, or eliminate a hazard by April 1, 2023, create procedures and documentation to monitor the compliance of the defined measures to prevent, reduce, or eliminate the hazard by April 15, 2023, fully implement your Food Safety Program by April 30, 2023, and conduct an (b)(4) review of your HACCP plan. In the meantime, you will conduct (b)(4) testing for colors and additives. However, you did not provide evidence indicating corrective actions are underway, including but not limited to a HACCP training registration confirmation, any in-progress documents, such as a hazard analysis, a HACCP plan, or results from your (b)(4) testing for colors and additives. You should note that per 21 CFR 120.7, you are required to develop a written hazard analysis to determine whether there are food hazards reasonably likely to occur for each type of juice you process, meaning you will likely need to conduct and/or revise multiple hazard analyses. Lastly, you stated you will conduct an (b)(4) review of your HACCP plan, but you did not indicate whether you will review and update your HACCP plans if the results of your hazard analyses could alter the HACCP plans in any way.

3. You did not implement the monitoring procedures listed in your HACCP plan, as required by 21 CFR 120.8(a).

Specifically, your firm's HACCP plans for your SuperShot and SuperAde products identify the use of a printer used to print out UV treatment data for every batch of juice processed. Your firm was found to not be using the printer or reviewing processing data to ensure there are no deviations from the critical limits during the treatment of raw juice.

We reviewed your response and determined it is incomplete. In your response, you stated you will work with the manufacturer of your UV equipment, as well as a third-party laboratory to “validate the process.” You will continue using and upgrading your UV Monitoring form and process and continue to follow manufacturer recommendations to ensure a robust data review process. The validation study will be performed from February 24, 2023, through June 30, 2023. During the process, you plan to involve the equipment manufacturer in providing recommendations and training for the operation, maintenance, and cleaning process. However, you did not provide evidence indicating corrective actions are in progress, including but not limited to a signed contract with the third-party company confirming your validation studies are underway, training logs, or any processing records, such as the UV Monitoring form. Additionally, you did not indicate how you will monitor processing data to ensure critical limits are not exceeded during the UV treatment of raw juice while corrective actions are being implemented.

4. You do not maintain sanitation standard operating procedure records that document the monitoring of conditions and practices during processing, as required by 21 CFR 120.6(c).

Specifically, your firm does not have documentation identifying the required parameters for conducting clean-in-place (CIP) operations. As a result, you are not protecting post UV treated juice from potential cross contamination by ensuring the cleanliness of food contact surfaces including piping, storage tanks, and fill nozzles. Further, you are not recording flow rate in (b)(4) as stated on your CIP/SIP Verification Log, a critical component to the effectiveness of a CIP system.

We reviewed your response and determined it is incomplete. In your response, you stated by June 30, 2023, the following will be completed: your written procedure with CIP operations parameters identified, your written procedure for post-UV process cleaning validation using the (b)(4), your UV process validation study, and your cleaning process validation study. However, you did not provide evidence indicating corrective actions are in progress, including but not limited to a signed contract with the third-party company confirming your validation studies are underway. Further, you did not indicate how you will ensure the safety of your products in the meantime, while utilizing equipment which requires validated parameters to be in place for the CIP system to effectively carry out the cleaning and sanitization.

5. Your HACCP plan does not list the verification procedures and frequencies that have been developed to ensure that the HACCP plan is being implemented, as required by 21 CFR 120.8(b)(6).

Specifically, your firm's HACCP Plans for both Supershot and SuperAde products do not identify calibration of the following devices used to control identified hazards as a verification step:
• (b)(4) UV machine used to treat the juice you manufacture to achieve the required 5-log pathogenic reduction
• (b)(4) pH meter used to verify the pH of in-process product identified on your HACCP plan as a control for bacterial growth

Further, though your HACCP Plans do not identify calibration of your pH meter as a verification step, you have an SOP for pH meter operation and calibration. However, your firm was found to not be implementing this written procedure.

We reviewed your response and determined it is incomplete. In your response, you stated you are currently working on revising procedures, forms, and work instructions as necessary to correct and improve “the Hazard Analysis,” and you are also creating new procedures for device calibration. You stated you began calibrating your (b)(4) pH meter on (b)(4), and you submitted a filled copy of your pH Meter Calibration Log, along with updated written procedures for pH meter calibration. However, you did not submit any in-progress documents, such as the above-mentioned procedures, forms, and work instructions you stated you are currently working on. Further, you did not indicate how you will ensure the safety of your products prior to verifying that your (b)(4) UV machine is properly calibrated.

6. You do not maintain records of calibration of process-monitoring instruments and periodic end-product or in-process testing, as required by 21 CFR 120.11(a)(2).

Specifically, your firm does not have records documenting calibration activities for the thermometers used to monitor and record temperature in the ingredient storage and finished product short term cooler spaces.

We reviewed your response and determined it is incomplete. In your response, you stated you will have a procedure for (b)(4) third-party calibration of your temperature measuring instruments by March 31, 2023. However, you did not provide evidence indicating corrective actions are underway, such as an in-progress written procedure. Further, you did not indicate how you will ensure the safety of your products while relying on temperature measuring instruments that have not been calibrated for accuracy.

The violations in this letter are not intended to be an all-inclusive list of the violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above 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. You should take prompt action to address the violations noted in this letter. Failure to promptly address these violations may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.

Please notify this office in writing within 15 working days of the receipt of this letter as to the specific steps you have taken to address these violations, including an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. In your response, you should include documentation, including revised procedures, photographs, results of tests you have conducted, and other useful information that would assist us in evaluating your corrections. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time within which you will do so.

Your written response should be sent electronically to: ORAHAFWEST5FirmResponses@fda.hhs.gov

Otherwise, a hardcopy can be sent to:

Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
1201 Harbor Bay Parkway
Alameda, CA 94502

Refer to Unique Identification Number CMS #653764 when replying.

If you have any questions regarding this letter, please contact Compliance Officer Sean Desbrow at sean.desbrow@fda.hhs.gov.

Sincerely,
/S/

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

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