FDA 483 - Becton Dickinson Infusion Therapy Systems, Inc. - March 26, 2026

Becton Dickinson Infusion Therapy Systems, Inc. in Sandy, UT, was cited for significant deficiencies in quality control, equipment cleaning, and microbial control during an FDA inspection. The firm failed to thoroughly investigate out-of-specification results, releasing affected drug products, and demonstrated inadequate cleaning validation and maintenance practices for manufacturing equipment. Additionally, procedures to prevent objectionable microorganisms in non-sterile drug products were not adequately established, particularly concerning bulk solution hold time studies.