B. Braun US Pharmaceutical Manufacturing LLC
Form 483 issued November 5, 2021 · Daytona Beach, Florida
- Inspection
- Oct 18 – Nov 5, 2021
- Investigators
- Mary A. Millner· Nakesha J. Jackson· Saundrea A. Munroe
- Observations
- 4
- Pages
- 8
- FEI number
- 3014200891
In short: On November 5, 2021, FDA issued a Form 483 with 4 observations to B. Braun US Pharmaceutical Manufacturing LLC in Daytona Beach, Florida (FEI 3014200891) after an inspection that ran Oct 18 – Nov 5, 2021. The investigators were Mary A. Millner, Nakesha J. Jackson and Saundrea A. Munroe. Most observations concern production and cAPA.
At a glance
Production and capa account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for corrective and preventive action have…
- 02
There was a failure to handle and store components at all times in a…
- 03
Reprocessing procedures lack the steps to be taken to insure that reprocessed batches will conform with…
- 04
Written production and process control procedures are not followed in the execution of production and process…
This inspection in context
Mary A. Millner
9 documents · 2015–2024
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Tennessee.
The firmB. Braun US Pharmaceutical Manufacturing LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at B. Braun US Pharmaceutical Manufacturing LLC?
FDA listed 4 observations on this Form 483, mostly about production, cAPA and materials. The opening words of each observation are shown on this page.
Who inspected B. Braun US Pharmaceutical Manufacturing LLC?
Mary A. Millner, Nakesha J. Jackson and Saundrea A. Munroe are named on this Form 483, for the inspection of Oct 18 – Nov 5, 2021. Each investigator has a profile showing what they cite most.
When was B. Braun US Pharmaceutical Manufacturing LLC inspected by FDA?
The inspection ran Oct 18 – Nov 5, 2021, and the Form 483 is dated November 5, 2021.
How do I get the full Form 483 for B. Braun US Pharmaceutical Manufacturing LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.