B. Braun US Pharmaceutical Manufacturing LLC
FDA inspection history in Daytona Beach, Florida, 2020 to 2025
- 4
- Form 483s
Every document, by year
- Form 483
2020: one Form 483; 2021: one Form 483; 2022: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020–22Three Form 483s, at Daytona Beach, Florida.
- 2020The longest 483 on file: 9 observations over 7 pages at Daytona Beach, Florida.
- 2025One Form 483, at Daytona Beach, Florida.
Cited most
Across all B. Braun US Pharmaceutical Manufacturing observations on file
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.160General requirements3
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
The complete B. Braun US Pharmaceutical Manufacturing file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Daytona Beach, Florida
Four Form 483s · 2020 to 2025 · 26 observations
Latest: Form 483, Jan 31, 2025 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-01-31 | 483 Form 483 | Daytona Beach, Florida | 8 | $99 |
| 2022-11-22 | 483 Form 483 | Daytona Beach, Florida | 5 | $99 |
| 2021-11-05 | 483 Form 483 | Daytona Beach, Florida | 4 | $99 |
| 2020-10-30 | 483 Form 483 | Daytona Beach, Florida | 9 | $99 |
Investigators on these documents
Evan Tong (1)Ileana Barreto-Pettit (1)Jessica L. Pressley (1)Jose Velez (1)Mary A. Millner (1)Michael T. Cyrus (1)Michelle K. Cockrell (1)Nakesha J. Jackson (1)Saundrea A. Munroe (1)Yaharn Su (1)
FEI number 3014200891 · most recent document Jan 31, 2025
About B. Braun US Pharmaceutical Manufacturing LLC
How many FDA Form 483s has B. Braun US Pharmaceutical Manufacturing LLC received?
FDA Intel has 4 Form 483s on file for B. Braun US Pharmaceutical Manufacturing LLC; the most recent is dated Jan 31, 2025.
When was B. Braun US Pharmaceutical Manufacturing LLC last inspected by FDA?
The most recent FDA inspection document on file for B. Braun US Pharmaceutical Manufacturing LLC is a Form 483 dated Jan 31, 2025, for the site in Daytona Beach, Florida.
What did FDA cite at B. Braun US Pharmaceutical Manufacturing LLC?
The regulations cited most in the observations on file for B. Braun US Pharmaceutical Manufacturing LLC are 21 CFR 211.100 (Written procedures; deviations), 3 times; 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times.