FDA issued a Warning Letter to a juice processor for issues associated with their HACCP plan. One was the failure to take appropriate corrective action to a process deviation, and the other was inadequate validation of their process.
"Review of your (b)(4) recording charts that monitor the (b)(4) critical limit of your citrus fruit (b)(4) treatment that uses (b)(4) to achieve a minimum 5-log reduction in the pertinent microorganism, revealed deviations from the critical limits identified in your Juice HACCP plan for cold pressed citrus juice with no corrective actions on November 11, 12, 15, and 16, 2021."
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/russ-davis-wholesale-inc-628195-04282022
WARNING LETTER
Russ Davis Wholesale Inc
MARCS-CMS 628195 — APRIL 28, 2022
2) The firm did not validate that the HACCP plan is adequate to control food hazards when a change in the process occurred that could have affected the hazard analysis or altered the HACCP plan in any way, as required by 21 CFR 120.11(b).
"Specifically, you had an outside laboratory perform a process validation study, dated March 21, 2021, to determine whether the (b)(4) is an effective (b)(4) treatment critical control point (CCP) to achieve a minimum 5-log reduction for the control of (b)(4). The validation concluded that (b)(4) provides a minimum 5-log reduction in lemons, mandarins, limes, and oranges; a (b)(4) is required for grapefruit. The validation further stated that verification of the (b)(4) is an important part of this CCP. Your firm started producing (b)(4) treated citrus juice in April 2021 without adequate verification of the (b)(4) treatment as performed at your facility."
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/russ-davis-wholesale-inc-628195-04282022
WARNING LETTER
Russ Davis Wholesale Inc
MARCS-CMS 628195 — APRIL 28, 2022