Specialty Process Labs LLC – FDA 483, Sep 15, 2023

Specialty Process Labs LLC in Phoenix, AZ, an API manufacturer, was cited for three significant issues during an FDA inspection. These included the quality unit's failure to ensure timely destruction of recalled drug products, a lack of documented procedures and control over laboratory samples and data, and the absence of a proper stability testing program for intermediates and APIs. The findings indicate serious deficiencies in quality control and data integrity.