FDA EIR - Vantage Specialties Inc - November 13, 2019

The FDA conducted a one-day inspection of Vantage Specialties Inc., also known as Vantage Specialty Chemicals, in Gurnee, IL, on November 13, 2019. The inspection focused on the company's manufacturing of food-grade emulsifiers, such as Polysorbate, which constitutes a significant portion of their business. The regulatory framework for this inspection was 21 CFR Part 117, covering Good Manufacturing Practices and Hazard Analysis and Risk-Based Preventive Controls for Human Food. During the inspection, two observations were noted: a puddle of cloudy standing water beneath a hand-sink and visible residues on piping situated above a production area. In a closeout meeting with management, immediate corrective actions were committed to. The company agreed to clean the sink area the same day and initiate a capital improvement request to properly address the area's grading. Additionally, they committed to having the production supervisor clean the affected piping by the end of the week. No further issues, such as pest activity or refusals, were documented, and no physical samples were collected. The facility was last inspected in 2014, with previous findings addressed.