A Bowling Green, KY juice maker is having trouble understanding how it can achieve a “5-log reduction in the pertinent microorganisms.”
In an Aug. 13 warning letter to Juice Pac Inc., the U.S. Food and Drug Administration said the juice processing facility must achieve the 5-log reduction in microorganisms in its juice concentrates.
A “5-log reduction” means lowering the number of microorganisms by 100,000-fold, meaning if a surface has 100,000 pathogenic microbes on it, a 5-log reduction would reduce the number of microorganisms to one.
After undergoing FDA inspection last May 4-6, Juice Pac wrote the agency suggesting steps it might take and asking if those actions would meet the “5-log reduction” standard.
In the warning letter, FDA told Juice Pac Inc. that taking those steps would not meet 5-log reduction. It suggests the juice maker rely on the “FDA Guidance for Industry” publication entitled “Guidance on Bulk Transport of Juice Concentrates and Certain Shelf Stable Juices.”
That means the steps Juice Pac Inc. was planning to take–including documenting that ingredients had received 5-log pathogen reduction, designating receiving juice concentrate ingredients as a critical control point, and documenting that drink base supplied to customers should be subjected to the 5-log reduction–would not meet the standard.
Without performing a 5-log reduction for its drink bases, without a juice Hazard Analysis and Critical Control Point (HACCP) plan, and proper sanitation control records, Juice Pac’s juice concentrates are “adulterated,” according to FDA.
The agency said, “…your juice concentrates are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.”
In the warning letter, FDA does give Juice Pac advice on how it might seek “enforcement discretion” as a single facility.
The warning letter gives Juice Pac 15 working days to get back to FDA’s Cincinnati district office with specific steps it plans to take to address the violations.