FDA 483 - Becton Dickinson Infusion Therapy Systems, Inc. - December 14, 2018

Becton Dickinson Medical Systems in Sandy, UT, was cited for multiple quality control and manufacturing process deficiencies during an FDA inspection. Observations included failures in Quality Assurance review of production records and data audit trails, inadequate investigation of out-of-specification results, and lack of proper control procedures for water manufacturing. Additionally, the firm failed to submit a required NDA-Field Alert Report for a contaminated drug product.