B. Braun US Pharmaceutical Manufacturing LLC
Form 483 issued November 22, 2022 · Daytona Beach, Florida
- Inspection
- Nov 8 – Nov 22, 2022
- Investigators
- Jose Velez· Michael T. Cyrus· Michelle K. Cockrell
- Observations
- 5
- Pages
- 8
- FEI number
- 3014200891
In short: On November 22, 2022, FDA issued a Form 483 with 5 observations to B. Braun US Pharmaceutical Manufacturing LLC in Daytona Beach, Florida (FEI 3014200891) after an inspection that ran Nov 8 – Nov 22, 2022. The investigators were Jose Velez, Michael T. Cyrus and Michelle K. Cockrell. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Quality system and laboratory controls account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
The quality control unit lacks the responsibility and authority to approve and…
- 03
Written production and process control procedures are not followed in the execution of production…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Jose Velez
24 documents · 2014–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
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 211.192
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 5 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected B. Braun US Pharmaceutical Manufacturing LLC?
Jose Velez, Michael T. Cyrus and Michelle K. Cockrell are named on this Form 483, for the inspection of Nov 8 – Nov 22, 2022. Each investigator has a profile showing what they cite most.
When was B. Braun US Pharmaceutical Manufacturing LLC inspected by FDA?
The inspection ran Nov 8 – Nov 22, 2022, and the Form 483 is dated November 22, 2022.
How do I get the full Form 483 for B. Braun US Pharmaceutical Manufacturing LLC?
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