# B. Braun US Pharmaceutical Manufacturing LLC – FDA 483, Jan 31, 2025

Source: https://www.keypedia.com/records/483/b-braun-us-pharmaceutical-manufacturing-llc/160cd675-7ceb-442f-8b3e-4fb499d922b3

> FDA 483 for B. Braun US Pharmaceutical Manufacturing LLC on January 31, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: B. Braun US Pharmaceutical Manufacturing LLC
- Inspection Date: 2025-01-31
- Product Type: drugs
- Office Name: Florida District Office
- Summary: 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.

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## Related Officers

- [Santos E. Camara](https://www.keypedia.com/people/santos-e-camara/18cea942-f6f9-4dec-9ce9-1c01c39009ce)

Company: https://www.keypedia.com/companies/b-braun-us-pharmaceutical-manufacturing-llc/9ed3959a-40a0-45d0-ba4b-e4dab3b3f3e4

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9