The issuance of a warning letter to a California juice company illustrates the importance of following all regulations applicable to your food business and responding in full, with corrective actions, to an FDA-issued 483.
Businesses that process juice are required to follow the Juice HACCP regulation. If not in full compliance, you may be subject to FDA enforcement actions, including a public warning letter. Such was the case with the juice company which was issued a warning letter with serious violations including:
- The facility’s HACCP plan did not include the required criteria for control measures delivering a 5-log reduction in the most heat-resistant microorganisms of public health concern to be in place at least as long as the product shelf life. Additionally, the process was not validated against Cryptosporidium parvum, E. coli O157:H7, and Salmonella.
- The HACCP plan did not list all physical, microbiological, and chemical hazards reasonably from colors and additives and heavy metals likely to occur in their products. Monitoring procedures were not implemented and no verification procedures were included related to calibration of process-monitoring various devices.
- Additionally, records of Sanitation SOPs were not maintained, specifically related to conducting CIP processes.
Although the facility had responded to the previously issued 483, which cited FDA inspection observations of non-compliance, the firm’s responses were deemed incomplete because they did not provide evidence that corrective actions were underway, thus causing the issuance of the Warning Letter.
