ISP Chemicals LLC – FDA EIR, Oct 2, 2019

An FDA inspection of ISP Chemicals LLC, located in Calvert City, KY, was conducted from September 30 to October 2, 2019. This marked the firm's initial FDA inspection to assess compliance with the Food Safety Modernization Act (FSMA), specifically 21 CFR Part 117, which outlines Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. The facility specializes in manufacturing polyclar/polyplasdone (PVPP), a clarifying intermediate food ingredient utilized in beverage and food production worldwide. The inspection's scope included a comprehensive review of the firm's manufacturing processes, food safety plan, product distribution, ingredient storage and receipt, and critical control points identified in their hazard analysis. Reviewed records encompassed labeling, receiving logs, Sanitation Standard Operating Procedures (SSOPs), employee training, and interstate commerce shipping documents. Crucially, the inspection concluded with no observations of deficiencies, and no Form FDA 483 was issued to ISP Chemicals LLC. As a result, the inspection was classified as "No Action Indicated" (NAI), signifying that no regulatory actions were required. Management was briefed on the FDA's inspection classification system during the close-out meeting.