Findings:
- "HACCP / HARPC Plan Q2-2023 dated 25 April 2023 lists the following Critical Limits identified at the Pasteurization Critical Control Point (CCP) (b)(4) limit). You have defined Organic Carrot Juice as a Category III product with a (b)(4). The (b)(4) is not sufficient to inactivate the spores of Clostridium botulinum in carrot juice."
- "Specifically, your HACCP / HARPC Plan Q2-2023 dated 25 April 2023 for fresh, refrigerated Organic Carrot Juice does not identify CCPs at labeling for maintaining product refrigeration, and of finished product refrigerated storage, to control the hazard of Clostridium botulinum growth and toxin formation in Organic Carrot Juice."
The pasteurization process would eliminate vegetative cells, but not spores including spores of Clostridium botulinum. Those spores would survive the pasteurization, and if held at temperatures above refrigeration temperature for sufficient time, the spores would germinate, and then the cells would grow producing toxin.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/barsotti-juice-company-inc-676447-01302024
Barsotti Juice Company, Inc.
MARCS-CMS 676447 — JANUARY 30, 2024
Recipient:
Barsotti Juice Company, Inc.
2239 Hidden Valley Lane
Camino, CA 95709
United States
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/barsotti-juice-company-inc-676447-01302024
Barsotti Juice Company, Inc.
MARCS-CMS 676447 — JANUARY 30, 2024
Recipient:
Barsotti Juice Company, Inc.
2239 Hidden Valley Lane
Camino, CA 95709
United States
Issuing Office:
Division of Human and Animal Food Operations West V
United States
WARNING LETTER
January 30, 2024
WL 676447
Dear Mr. Barsotti:
We inspected your juice processing facility, located at 2239 Hidden Valley Lane, Camino, CA on November 20, November 21 and December 1, 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), and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule) in Title 21, Code of Regulations, Part 117 (21 CFR part 117). In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with this section 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 organic carrot juice is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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.
At the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483, Inspectional Observations. You provide a written response to the inspection on December 15, 2023, which included a justification of your pathogen control measures, HACCP/HARPC Plan specific to organic carrot juice, and photographs. We have reviewed the documentation and continue to have serious concerns with your HACCP program.
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 / HARPC Plan Q2-2023 dated 25 April 2023 lists the following Critical Limits identified at the Pasteurization Critical Control Point (CCP) (b)(4) limit). You have defined Organic Carrot Juice as a Category III product with a (b)(4). The (b)(4) is not sufficient to inactivate the spores of Clostridium botulinum in carrot juice.
You provided our investigator a challenge study entitled “(b)(4)” to support your critical limit and biological hazards identified for the Pasteurization CCP during the current inspection. Your written response included a justification which explained that “the current thermal processing eliminates all vegetative cells effectively.” Further, it explained “In the event of temperature abuse the growth of aerobic organism competitively prevents C. botulinum spore germination and growth, if present, and other undesirable biochemical changes cause the quality of the Carrot juice to degrade rapidly before the expiration date making the product undrinkable.”
We reviewed your challenge study and written response and find them inadequate. The critical limits specified at the Pasteurization CCP (b)(4) is insufficient in ensuring control over any types of strains of C. botulinum, posing a serious risk to consumers due to the potential for spore growth and toxin production. (b)(4) for at least (b)(4).
Your challenge study does not provide scientific rationale and sufficient data to demonstrate that C. botulinum is not a hazard in your carrot juice. Historical outbreak data demonstrates that C. botulinum is the pertinent microorganism in refrigerated carrot juice. Furthermore, the study does not support the shelf-life of the product which is defined as 28 days.
2. Your HACCP plan does not list the critical control points for each of the identified food hazards that is reasonably likely to occur as required per 21 CFR 120.8(b)(2).
Specifically, your HACCP / HARPC Plan Q2-2023 dated 25 April 2023 for fresh, refrigerated Organic Carrot Juice does not identify CCPs at labeling for maintaining product refrigeration, and of finished product refrigerated storage, to control the hazard of Clostridium botulinum growth and toxin formation in Organic Carrot Juice.
As part of your written response, you provided a revised HACCP/HARPC Plan Q4-2023 for Processed Organic Carrot Juice which identifies Pasteurized Storage Tanks, Finished Food Storage and Labeling steps as critical control points for “biological.” The biological hazard is not defined to identify the pertinent microorganism of C. botulinum.
Further, the current Juice HACCP Hazards and Controls Guidance, First Edition, states control measures for Low-acid juices, such as carrot juice “are likely to involve multiple measures, e.g., a combination of a process step to destroy the non-proteolytic spores and measures to ensure that "Keep Refrigerated" labeling is used for the juice if the juice does not receive a treatment sufficient to destroy the proteolytic spores.” As explained above, your pasteurization process is insufficient to destroy the non-proteolytic spores; therefore, these additional control measures alone do not adequately control the C. botulinum hazard.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed 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 and FDA regulations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to do so 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.
We are concerned about your lack of 5-log reduction in the most resistant microorganism of public health significance which has been identified as clostridium botulinum and the limited controls you have in place. We believe a meeting with us to discuss the violations and corrective actions you may take would be beneficial to your firm and the FDA. A meeting would provide an opportunity for you to present any questions you may have regarding implementation of corrections and for the FDA to assist you in achieving full compliance.
We have scheduled a regulatory meeting to be held through conference call on Wednesday, February 21, 2024 at 9:00 AM PST. Upon receipt of this letter please contact Kimberly M. Lichter, Compliance Officer at 949-608-2967 or at Kimberly.lichter@fda.hhs.gov within five (5) business days to confirm or request an alternate date. Please provide documentation of any corrective actions you have taken, or intend to take, five (5) business days prior to the conference call to allow for review by FDA prior to the conference call.
Your written response should 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 676447 when replying.
If you prefer to send your response electronically, please email it to ORAHAFWEST5FirmResponses@fda.hhs.gov. Please include the name of your firm and the Unique Identification number in the title of the e-mail message.
If you have any questions regarding this letter, please contact Kimberly Lichter, Compliance Officer, at kimberly.lichter@fda.hhs.gov or (949) 608-2967.
Sincerely,
/S/
Darla R. Bracy
Program Division Director
Office of Human and Animal Food Operations – West Division 5
Division of Human and Animal Food Operations West V
United States
WARNING LETTER
January 30, 2024
WL 676447
Dear Mr. Barsotti:
We inspected your juice processing facility, located at 2239 Hidden Valley Lane, Camino, CA on November 20, November 21 and December 1, 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), and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule) in Title 21, Code of Regulations, Part 117 (21 CFR part 117). In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with this section 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 organic carrot juice is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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.
At the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483, Inspectional Observations. You provide a written response to the inspection on December 15, 2023, which included a justification of your pathogen control measures, HACCP/HARPC Plan specific to organic carrot juice, and photographs. We have reviewed the documentation and continue to have serious concerns with your HACCP program.
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 / HARPC Plan Q2-2023 dated 25 April 2023 lists the following Critical Limits identified at the Pasteurization Critical Control Point (CCP) (b)(4) limit). You have defined Organic Carrot Juice as a Category III product with a (b)(4). The (b)(4) is not sufficient to inactivate the spores of Clostridium botulinum in carrot juice.
You provided our investigator a challenge study entitled “(b)(4)” to support your critical limit and biological hazards identified for the Pasteurization CCP during the current inspection. Your written response included a justification which explained that “the current thermal processing eliminates all vegetative cells effectively.” Further, it explained “In the event of temperature abuse the growth of aerobic organism competitively prevents C. botulinum spore germination and growth, if present, and other undesirable biochemical changes cause the quality of the Carrot juice to degrade rapidly before the expiration date making the product undrinkable.”
We reviewed your challenge study and written response and find them inadequate. The critical limits specified at the Pasteurization CCP (b)(4) is insufficient in ensuring control over any types of strains of C. botulinum, posing a serious risk to consumers due to the potential for spore growth and toxin production. (b)(4) for at least (b)(4).
Your challenge study does not provide scientific rationale and sufficient data to demonstrate that C. botulinum is not a hazard in your carrot juice. Historical outbreak data demonstrates that C. botulinum is the pertinent microorganism in refrigerated carrot juice. Furthermore, the study does not support the shelf-life of the product which is defined as 28 days.
2. Your HACCP plan does not list the critical control points for each of the identified food hazards that is reasonably likely to occur as required per 21 CFR 120.8(b)(2).
Specifically, your HACCP / HARPC Plan Q2-2023 dated 25 April 2023 for fresh, refrigerated Organic Carrot Juice does not identify CCPs at labeling for maintaining product refrigeration, and of finished product refrigerated storage, to control the hazard of Clostridium botulinum growth and toxin formation in Organic Carrot Juice.
As part of your written response, you provided a revised HACCP/HARPC Plan Q4-2023 for Processed Organic Carrot Juice which identifies Pasteurized Storage Tanks, Finished Food Storage and Labeling steps as critical control points for “biological.” The biological hazard is not defined to identify the pertinent microorganism of C. botulinum.
Further, the current Juice HACCP Hazards and Controls Guidance, First Edition, states control measures for Low-acid juices, such as carrot juice “are likely to involve multiple measures, e.g., a combination of a process step to destroy the non-proteolytic spores and measures to ensure that "Keep Refrigerated" labeling is used for the juice if the juice does not receive a treatment sufficient to destroy the proteolytic spores.” As explained above, your pasteurization process is insufficient to destroy the non-proteolytic spores; therefore, these additional control measures alone do not adequately control the C. botulinum hazard.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed 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 and FDA regulations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to do so 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.
We are concerned about your lack of 5-log reduction in the most resistant microorganism of public health significance which has been identified as clostridium botulinum and the limited controls you have in place. We believe a meeting with us to discuss the violations and corrective actions you may take would be beneficial to your firm and the FDA. A meeting would provide an opportunity for you to present any questions you may have regarding implementation of corrections and for the FDA to assist you in achieving full compliance.
We have scheduled a regulatory meeting to be held through conference call on Wednesday, February 21, 2024 at 9:00 AM PST. Upon receipt of this letter please contact Kimberly M. Lichter, Compliance Officer at 949-608-2967 or at Kimberly.lichter@fda.hhs.gov within five (5) business days to confirm or request an alternate date. Please provide documentation of any corrective actions you have taken, or intend to take, five (5) business days prior to the conference call to allow for review by FDA prior to the conference call.
Your written response should 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 676447 when replying.
If you prefer to send your response electronically, please email it to ORAHAFWEST5FirmResponses@fda.hhs.gov. Please include the name of your firm and the Unique Identification number in the title of the e-mail message.
If you have any questions regarding this letter, please contact Kimberly Lichter, Compliance Officer, at kimberly.lichter@fda.hhs.gov or (949) 608-2967.
Sincerely,
/S/
Darla R. Bracy
Program Division Director
Office of Human and Animal Food Operations – West Division 5
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