FDA 483 - Actavis Laboratories UT, Inc. - September 19, 2025

During an inspection conducted from September 15-19, 2025, Actavis Laboratories UT, Inc. received an FDA Form 483, detailing significant observations related to manufacturing practices. The document, issued under the Federal Food, Drug and Cosmetic Act, highlighted multiple areas requiring immediate attention to ensure product quality and safety. Key issues included inadequate procedures for preventing objectionable microorganisms. Specifically, the firm's disinfectant efficacy studies failed to include testing against relevant environmental isolates like Bacillus subtilis, and environmental sampling methods lacked crucial detail, leading to inconsistent data collection. This was noted as a repeat observation. Furthermore, investigations into microbial contamination, such as the recovery of Streptococcus spp. in a mixing room for distributed products, lacked complete conclusions and effective corrective actions to address identified root causes like uncontrolled air infiltration. The inspection also revealed equipment design deficiencies; mixing tanks exhibited scratches and pitting that compromise cleaning effectiveness, and a hopper cover had a hole, posing contamination risks. Lastly, the facility was not maintained in a clean and sanitary condition, with visible cleaning agent residue on walls and a failure to follow internal cleaning verification procedures. Actavis Laboratories must address these observations by implementing robust corrective and preventive actions to ensure compliance and prevent product contamination.