FDA 483 - HNC Products Inc. - August 24, 2021

HNC Products Inc. in Clinton, IL, was inspected and cited for significant deficiencies across its laboratory, quality, and facilities & equipment systems. The inspection revealed issues with inadequate laboratory controls for component and water testing, a deficient quality control unit lacking proper procedures and audit trail review, and failures in routine equipment calibration and monitoring, including temperature excursions in stability chambers. Additionally, cleaning validation for manufacturing equipment was found to be insufficient.