FDA 483 - ISP Chemicals LLC - July 14, 2025

An FDA inspection of ISP Chemicals LLC, an API manufacturer in Calvert City, KY, identified two significant issues. The firm failed to use validated and stability-indicating test procedures, specifically lacking a degradation study and established potential degradation products for their API. Additionally, the inspection found that sampling procedures for finished API drug products were not scientifically justified, leading to non-representative samples for quality assessment.