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Inadequate HACCP Elicits Warning Letter

The lack of an adequate HACCP plan was the basis of a warning letter sent to a California juice processing facility.

Citing inadequacies against the hazard of C. botulinum, the warning letter states that the facility’s HACCP plan does not include control measures that will consistently produce a 5-log reduction in C. botulinum – the most resistant microorganism of public health significance that is likely to occur in the juice throughout the product’s shelf life. Specifically, the inspectors observed the lack of a valid heat inactivation control and the lack of an identified control of the maintenance of finished product refrigeration during storage.

Although the facility had provided a challenge study and written response to the initial citations, FDA found them inadequate with the critical limits specified at the Pasteurization CCP insufficient to ensure control over any types of strains of C. botulinum.

Ensuring that the facility HACCP plan list the critical control points for each of the identified food hazards that is reasonably likely to occur is required by 21 CFR 120.8(b)(2). Thus, it is critical that a facility consider all hazards and set controls for all that are reasonably likely to occur.


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