FDA 483 - ISP Chemicals LLC - July 14, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 55e52891-ecb6-471c-83d5-5800cc4c3208