FDA 483 - B. Braun Medical Inc. - November 05, 2021

B. Braun Medical Inc., a sterile drug manufacturer in Daytona Beach, FL, received a Form 483 with four observations. The inspection revealed significant issues including inadequate CAPA procedures, failure to control microbial contamination in the Water for Injection system, unvalidated reprocessing steps for IV bags, and non-adherence to visual inspection procedures and qualification requirements. These findings indicate a moderate level of severity regarding quality system deficiencies and potential product integrity risks.