Givaudan Flavor Corp. – FDA EIR, Oct 8, 2019

An FDA inspection of Givaudan Flavor Corp., a flavor manufacturer located in East Hanover, NJ, was conducted on October 8, 2019. This inspection was part of the FY'19 workplan, adhering to the guidance for Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventive Controls in Human Foods Inspections. The inspection comprehensively reviewed various aspects of the facility's operations. Key areas examined included records for employee training, environmental monitoring, and cleaning and sanitation procedures. Investigators found no deviations or deficiencies in any of these critical areas. Furthermore, the facility was free of any observed rodent, insect, or avian activity, indicating effective pest control. Notably, the inspection revealed no changes in manufacturing operations since the previous assessment in 2015, which was also classified as "No Action Indicated" (NAI). The firm's laboratory operations, including equipment calibration and product evaluations, were also found to be compliant. Givaudan Flavor Corp. demonstrated a robust recall procedure and confirmed no health-related complaints since the last inspection. As a result of these positive findings, the FDA did not issue any Form 483 Inspectional Observations, nor were any samples collected. Therefore, no violations were identified, and no specific corrective actions were required from the company following this inspection.