B. Braun Medical Inc – FDA EIR, May 11, 2016

The FDA conducted an unannounced pre-approval inspection and follow-up to open Field Alert Reports at B. Braun Medical Inc. in Irvine, CA, from April 18 to May 11, 2016. The inspection aimed to assess compliance for pending drug applications and verify corrective actions from previous inspections, focusing on the company's sterile drug manufacturing processes for large and small volume parenterals. The regulatory framework for this inspection was based on Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act and FDA Good Manufacturing Practice (GMP) regulations, 21 CFR Parts 210 and 211. The inspection identified nine significant observations, documented on an FDA-483 form, some of which were repeat deficiencies. Key issues included inadequacies in equipment design, incomplete equipment logs, and a recurring failure of the quality control unit to fully adhere to its responsibilities. The company also failed to thoroughly investigate discrepancies and batch failures, lacked established in-process controls, and had deficient master production records. Laboratory controls and adherence to test procedures were also found lacking. Additionally, the firm's change management system was inadequate, and environmental monitoring issues, such as repeated excursions on the Glass Filling Line Conveyor Belt, persisted without sufficient corrective actions. A recall was in progress for Dextrose Injection due to microbial contamination from leaking containers. B. Braun Medical Inc. committed to providing a written response to the FDA-483 observations within 15 working days.