FDA 483 - ABS Corporation - January 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.