FDA 483 - Biotest AG - June 20, 2025

Biotest AG, located in Dreieich, Germany, underwent an FDA inspection from June 12 to June 20, 2025, regarding its manufacturing of Fibrinogen (Human) drug products. The resulting report identified significant violations in quality management and facility maintenance. A major issue involved the frequent misuse of temporary deviations to bypass standard quality requirements, such as calibration and maintenance deadlines, without implementing corrective actions or trend analyses. Inspectors also observed critical failures in aseptic control, including operators failing to sanitize or change gloves after touching the floor or trash bins, and improper disinfectant use near open product containers. Additionally, the facility and equipment were found to be in poor repair, characterized by rust, chipping paint, metal shavings, and residues in sterile areas. The company"s cleaning validation studies were also deemed inadequate for failing to test against representative surfaces and local microorganisms. Finally, the laboratory"s testing assays lacked proper calibration against international standards. This inspection was conducted under Section 704 of the Federal Food, Drug, and Cosmetic Act. Biotest AG is expected to address these observations by discussing objections or planned corrective actions with the FDA and submitting a formal written response to the agency. These findings serve as a notification of objectionable conditions that require immediate attention to ensure compliance with federal safety and quality standards.