Liberty Fruit Co. Inc. DBA Carol’s Cuts

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March 24, 2023

Re: Case: 651401

WARNING LETTER

Dear Mr. McClelland,

On November 7, 2022 – December 2, 2022 the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at Liberty Fruit Co Inc. DBA Carol’s Cuts, 1251 Argentine Blvd., Kansas City, KS 66105, where you manufacture 100% juices, salsa, and RTE cut produce. Based on the inspectional findings, we have identified a serious violation of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on the FDA’s home page at www.fda.gov.

Adulterated Juices

The inspection revealed serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR 120). In accordance with 21 CFR 120, failure of a processor to have or implement a HACCP plan that complies with the requirements of 21 CFR 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, the juice you manufacture is adulterated in that the juice has been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.

The significant violation is as follows:

You did not validate that your HACCP plan is adequate to control food hazards when a change in the process occurred that could have affected the hazard analysis or altered the HACCP plan in any way, as required by 21 CFR Part 120.11(b). Therefore, it is unclear whether the critical limits of (b)(4) listed in your High Pressure Processing (HPP) agreement with (b)(4) are adequate to produce a minimum 5-log reduction in the pertinent microorganism, as required by HACCP 21 CFR 120.24(a). Specifically,

You explained you had made formulation changes in December 2021 to three juices, Tangy Turmeric, Smooth Avocado and Citrus Sunrise. In January 2022, you sent your Processing Authority, who had performed your HPP validation in 2020, representative samples of the three juices, but failed to notify them the formulation had changed (same ingredients, but different percentage of ingredients). At the conclusion of the current inspection, you indicated you would provide the percentage of ingredients information to the Processing Authority and provide FDA a copy of the letter from the Processing Authority. In addition, in the future you indicated you would provide your Processing Authority with all formulation changes as well as representative samples when you alter the process and/or formulations of your juice HACCP products.

You responded via email dated 12/16/2022 to the Observations listed on the FDA 483. Your response included a copy of a letter dated 12/16/2022 from your Processing Authority. The Processing Authority found an increase of pH by more than (b)(4) units. The letter stated, “The re-formulation of (b)(4) to SMOOTH AVOCADO resulted in an increase in pH of more than (b)(4) units ((b)(4)). Note that pH is on a logarithmic scale (i.e., 𝑝𝑝𝑝𝑝= −log[𝐻 +]), so an increase of (b)(4) pH units means cutting [𝐻 +] ions in the solution by (b)(4). This is a significant change in product pH that may necessitate a new HPP validation study.”

FDA agrees with the Processing Authority’s recommendation for Smooth Avocado, that due to the change in pH (b)(4) of the juice the HPP validation study should be re-validated. This is because vegetative cells of bacteria are more susceptible to pressure at lower pH values and decreasing the acidity (i.e., raising the pH) generally results in a decrease in microbial lethality from HPP. Your 12/16/2022 response to FDA did not explain what steps you have taken in response to the Processing Authority’s findings in their 12/16/2022 letter.

FDA also finds that the Citrus Sunrise °Brix increased from (b)(4) to (b)(4) and the Tangy Turmeric °Brix increased (b)(4) to (b)(4), and the HPP parameters were not revalidated following the formulation changes. Increasing the Brix levels in juices reduces the water activity (aw) and typically results in enhanced pressure resistance of microorganisms.

This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act, the juice HACCP regulation (21 CFR Part 120), and the Current Good Manufacturing Practice regulation (21 CFR Part 117). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including seizure and injunction.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the 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 action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

Your written response can be sent to the following address: U.S. Food and Drug Administration, 8050 Marshall Drive, Suite 205, Lenexa, Kansas 66214, to the attention of Kara L. Roden, Compliance Officer or email at ORAHAFWEST2FirmResponses@fda.hhs.gov. If you have any questions regarding this letter please contact Kara L. Roden, Compliance Officer, at 913-495-5121 or email at Kara.Roden@fda.hhs.gov.

Sincerely,
/S/

LaTonya M. Mitchell, Ph.D.
District Director | Kansas City District Office (KS, MO, IA, NE)
Program Division Director | Office of Human and Animal Food Operations – Division West II