FDA 483 - ISP Chemicals LLC - January 29, 2024

ISP Chemicals LLC, an API manufacturer in Columbus, OH, was cited for significant deficiencies in its stability testing methods. The inspection revealed that validation methods for Flunixin Meglumine and Mitotane, dating back to 1996, were not properly stability-indicating, lacking appropriate instrumentation for co-elution detection. Furthermore, the firm failed to follow its own standard operating procedures for conducting stress studies, resulting in insufficient degradation for all test conditions.