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.

Barsotti Juice Company Inc.
Camino, CA

The FDA has warned a juice processing company in California about serious violations of the Hazard Analysis and Critical Control Point regulation, and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.

In a Jan. 30 warning letter, the FDA described Nov. 20-21 and Dec. 1, 2023, inspections of Barsotti Juice Company, Inc.’s processing facility in Camino, CA.

The FDA’s inspection revealed that the firm was not in compliance with federal regulations, which resulted in the issuance of an FDA Form 483. Some of the significant violations are as follows:

1. The firm’s 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.

Specifically, their HACCP / HARPC Plan Q2-2023 dated 25 April 2023 lists the following Critical Limits identified at the Pasteurization Critical Control Point (CCP) (redacted) limit). The firm has defined Organic Carrot Juice as a Category III product with a (redacted). The (redacted) is not sufficient to inactivate the spores of Clostridium botulinum in carrot juice.

The firm provided an FDA investigator with a challenge study entitled “(redacted)” to support their critical limit and biological hazards identified for the Pasteurization CCP during the current inspection. The firm’s 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.”

FDA reviewed their challenge study and written response and find them inadequate. The critical limits specified at the Pasteurization CCP (redacted) 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. (Redacted) for at least (redacted).

The firm’s challenge study does not provide scientific rationale and sufficient data to demonstrate that C. botulinum is not a hazard in their 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. The firm’s HACCP plan does not list the critical control points for each of the identified food hazards that is reasonably likely to occur as required.

Specifically, their 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 their written response, they 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, their 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 full warning letter can be viewed here.

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