483
ISP Chemicals LLCISP Chemicals LLC – FDA 483, Jul 14, 2025
Record Details
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.
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ID · 55e52891-ecb6-471c-83d5-5800cc4c3208
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