FDA EIR - Italian Rose Garlic Products, LLC - September 06, 2018

An FDA inspection of Italian Rose Garlic Products, LLC, an acidified condiment manufacturer in Riviera Beach, FL, was conducted from September 5-6, 2018. The inspection assessed the company's manufacturing practices and preventive controls program for refrigerated fresh salsa, ensuring compliance with Title 21 CFR Part 117, which governs Current Good Manufacturing Practice and Risk-Based Preventive Controls for Human Food. Significantly, no Form FDA 483, Inspectional Observations, was issued during this visit. Previous issues from a March-April 2018 inspection, concerning pH control testing and equipment design to prevent allergen cross-contact, were largely observed as corrected. Allergen ingredient storage procedures were also improved. However, two verbal observations were noted: overspray during production line cleaning in proximity to ongoing manufacturing, which was a recurring issue, and the temporary use of large cardboard shipping totes for fresh tomatoes placed directly on wooden pallets, raising potential contamination concerns. The company's Director of Food Safety and Quality Assurance committed to implementing voluntary corrective actions for these verbal observations.