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•United States

B. Braun US Pharmaceutical Manufacturing LLC, Daytona Beach, FL – FDA Inspections

Inspection records and compliance data for B. Braun US Pharmaceutical Manufacturing LLC in Daytona Beach, Florida. 3 FDA inspections on record, 2 Form 483s, last inspected September 25, 2026.

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Company Profile

This profile covers B. Braun US Pharmaceutical Manufacturing LLC based in Daytona Beach, Florida, United States.

FDA Inspection History

FDA inspections
3
OAI
0
VAI
2
NAI
0
Unclassified
1
Form 483s
2
Warning letters
0

First inspected November 22, 2022. Last inspected September 25, 2026.

Most cited issue areas

  • In-process conformity - examination, sample testing2 inspections
  • Investigations of discrepancies, failures2 inspections
  • Procedures for sterile drug products2 inspections

FDA inspections (3)

DateResultFDA center(s)Insp. #
September 25, 2026Not classifiedHuman Drugs · Drug Quality Assurance1334920
January 31, 2025VAIHuman Drugs · Drug Quality Assurance1252695
November 22, 2022VAIHuman Drugs · Drug Quality Assurance1191429
FDA documents

Form 483s (4)

  • Form 483s · January 31, 2025
  • Form 483s · November 22, 2022
  • Form 483s · November 5, 2021
  • Form 483s · October 30, 2020
People (6)
Ileana Barreto-Petit
Person
Jessica L. Pressley
Person
Mary A. Millner
Person
Nakesha J Jackson
Person
Michelle K Cockrill
Person
Michael T. Cyrus
Person
Related Companies (10)

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FRESENIUS MEDICAL CARE ANDINA S A S
Industria Farmaceutica Galenica Senese Srl
Glenmark Pharmaceuticals Inc USA
Berkshire Sterile Manufacturing, LLC
Par Formulations Private Limited
Company Information

Name

B. Braun US Pharmaceutical Manufacturing LLC

FEI Number

3014200891

Address

1845 Mason Ave, Daytona Beach, Florida 32117, United States

Country

United States

ID: 9ed3959a-40a0-45d0-ba4b-e4dab3b3f3e4

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