FDA 483 - AbbVie Bioresearch Center - December 16, 2025

AbbVie Bioresearch Center in Worcester, MA, was inspected by the FDA from December 8-16, 2025. The inspection resulted in a significant observation documented on an FDA Form 483, highlighting a critical deficiency in the company's sanitation program. The primary issue identified was the failure to use a properly validated disinfectant to effectively control spore-forming microorganisms during routine cleaning operations in production areas. Specifically, an internal disinfectant efficacy study, approved in June 2024, demonstrated that the disinfectant routinely used by AbbVie did not achieve the required effectiveness at its standard contact time when tested against a particular microorganism on various manufacturing surfaces. Despite these conclusive study results, the firm continued to apply this disinfectant at the inadequate contact time as part of its daily sanitation regimen. This included its use on critical equipment such as biosafety cabinets, product equipment, and raw materials within ISO-5, ISO-7, and ISO-8 classified production zones, where bulk drug substance intermediate manufacturing takes place. This observation indicates a deviation from current Good Manufacturing Practices (cGMP) under the Federal Food, Drug, and Cosmetic Act. AbbVie Bioresearch Center is now expected to promptly address this finding by implementing comprehensive corrective and preventive actions. These actions should ensure the validation and consistent use of disinfectants proven effective for their intended purpose, thereby rectifying the identified deficiencies in their environmental control strategy.