FDA EIR - Innova SoftGel LLC - March 14, 2019

Innova SoftGel LLC, a manufacturer of OTC drugs and dietary supplements, was subject to a comprehensive FDA inspection from February 20 to March 14, 2019. This inspection, operating under cGMP regulatory frameworks for both drugs and dietary supplements, identified significant issues and resulted in a twelve-item FDA-483. Major violations impacting both product lines included a failure to adequately investigate potential metal shaving contamination on gelatin capsule shells during imprinting, and a deficient USP Water System lacking appropriate monitoring, maintenance, and temperature control, with observed leaks. The firm also exhibited inadequate in-house microbiological test procedures, with instances of omitted release testing for drug batches, scientifically unfounded invalidation of out-of-specification results, and insufficient growth promotion testing for media. For drugs, additional concerns included inadequate cleaning validation, insufficient prevention of cross-contamination, and a lack of quality unit oversight across manufacturing, quality control, and product release. Dietary supplement operations further demonstrated uncontrolled manufacturing with cross-contamination potential, inconsistent quality unit authorization for nonconforming product disposition, and a failure to maintain reserve samples for all batches. Innova SoftGel's President and CEO, Scott Woodruff, committed to implementing voluntary corrective actions and providing a written response to the FDA within fifteen business days, along with pledging to test retain samples for quality or safety impacts and initiate immediate recalls if necessary. New management initiated corrective measures before the inspection concluded.