483
B. Braun US Pharmaceutical Manufacturing LLCB. Braun US Pharmaceutical Manufacturing LLC – FDA 483, Jan 31, 2025
Record Details
An FDA inspection of B. Braun Medical Inc. in Daytona Beach, FL, revealed significant deficiencies in their sterile drug manufacturing processes. Observations included incorrect yield calculations in batch records, failures in preventing microbiological contamination, and inadequate facility space for material storage. Additionally, the firm's examination and testing procedures for drug products were found to be insufficient.
- Office
- Florida District Office
- Person
View Company Profile
ID · 160cd675-7ceb-442f-8b3e-4fb499d922b3
Other documents for B. Braun US Pharmaceutical Manufacturing LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.