FDA WARNING_LETTER - ABS Corporation - January 16, 2026

Following an inspection from January 12 to 16, 2026, the FDA issued a warning letter to ABS Corporation regarding significant manufacturing violations at its Omaha, Nebraska facility. The company failed to comply with Current Good Manufacturing Practice (CGMP) standards, leading to the production of animal drugs that do not meet federal quality and safety requirements under the Federal Food, Drug, and Cosmetic Act.

The main violations involve a systemic failure to investigate batch failures and "out-of-specification" (OOS) results. Specifically, the firm released products despite failed quality tests, in some cases by averaging results to hide discrepancies or manually altering laboratory specifications without scientific justification. Furthermore, the company did not adequately test incoming raw materials for purity—including high-risk ingredients like glycerin—and used expired materials in production even after they failed retesting. The FDA also identified a lack of formal manufacturing validation, meaning the company cannot ensure its processes consistently produce drugs of the required strength and quality.

Because the company’s initial response failed to address the risks to products already distributed to the market, the FDA requires several immediate actions. ABS Corporation must hire a qualified independent consultant to conduct a full audit of its quality and material systems. They must also provide a detailed plan for remediating their investigation procedures, supplier qualifications, and process validation protocols. A comprehensive response detailing these improvements and specific timelines for completion must be submitted to the FDA within 15 working days.