ABS Corporation – FDA 483, Jan 16, 2026

ABS Corporation, an animal drug manufacturer in Omaha, NE, was cited for significant deficiencies across its quality system. The inspection revealed failures in thoroughly investigating out-of-specification results and deviations, inadequate component sampling and testing, and a lack of robust process validation and change control procedures. Additionally, the firm failed to routinely calibrate critical equipment and maintain proper calibration documentation.